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Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/g Gel — NDC 68682-0132-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/g Gel — NDC 68682-132-50 (Billing 68682-0132-50)

by Oceanside Pharmaceuticals · 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP

This is a package of Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/g Gel from Oceanside Pharmaceuticals, marketed since Jul 2018 and currently FDA-listed; retail pharmacies pay about $1.33 per g (NADAC). It is this product's only package size.

NDC 68682-0132-50
🏷️ FDA NDC (as labeled) 68682-132-50 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68682-132-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68682 labeler · 132 product · 50 package
Package marketed since
Jul 2, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6868213250 2
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68682-132-50
Product NDC 68682-132
11-digit billing NDC 68682013250
NCPDP billing unit GM — per gram (weight)
RxCUI 885131
UNII EH6D7113I8, W9WZN9A0GM
Application # NDA050819
SPL Set ID edae294f-cc8b-4f94-8d90-4c764fda307b
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-02
Route TOPICAL
Dosage form GEL
Substance CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90059902194030
GPI class Clindamycin Phos-Benzoyl Perox
GCN Seq No 066978
GCN 29418
HICL code 017263
Ingredient (HICL) Clindamycin Phos/Benzoyl Perox
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5H
Therapeutic class — specific (HIC3) Acne Agents,Topical
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLIND PH-BENZOYL PERO 1.2-2.5%
FDB brand name Clindamycin Phos-Benzoyl Perox
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066978
  • GCN: 29418
  • GPI-14 (Medi-Span): 90059902194030
  • HICL (First Databank): 017263
  • AHFS class code: 08:12.28.20
  • RxCUI (RxNorm): 885131
Why two NDCs? The FDA registers this code as 68682-132-50 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68682-0132-50. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Peroxides class.

Drug family (ATC) Peroxides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CLIND PH-BENZOYL PERO 1.2-2.5% Ingredient Clindamycin Phos/Benzoyl Perox
📗 Our plain-language guide HelloPharmacist
  • It treats acne vulgaris, the common type of acne, in people 12 and older. It combines an antibiotic, clindamycin, with benzoyl peroxide, which kills bacteria and helps your skin sh...
  • Wash your face gently with a mild soap, rinse with warm water and pat dry. Then apply a pea-sized amount to your face once a day. Keep it away from your eyes, mouth and broken skin...
  • Mild skin reactions like burning, itching, rash, redness, scaling and stinging can happen. They tended to peak around week 4 and improve by week 12. If irritation sticks around, te...
  • Stop the gel and call right away if you get significant diarrhea, bloody diarrhea or bad belly cramps, since clindamycin can cause colitis. Also get emergency help for signs of a s...
📖 Read our full Clindamycin and Benzoyl Peroxide Topical guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $1.330 $66.48 / 50 g
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $1.964 $0.830
▼ Down 15% over the last 14 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68682-0132-50 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP 2018-07-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin phosphate and benzoyl peroxide 25 mg/g; 10 mg/g 00591-3916-68 Actavis 1 bottle $0.767 — Discontinued save 42%
Clindamycin Phosphate And Benzoyl Peroxide 10 mg/g; 25 mg/g 21922-0074-40 Encube 1 bottle $0.819 AB Availability likely save 38%
Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g 45802-0597-01 Padagis 1 bottle $0.819 AB Availability likely save 38%
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/g 51672-1367-03 Sun 1 bottle $0.819 AB Availability likely save 38%
Clindamycin Phosphate and Benzoyl Peroxide 10 mg/g; 25 mg/gthis 68682-0132-50 Oceanside 1 bottle $1.330 AB FDA listed —
Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g 63629-8635-01 Bryant 1 bottle — AB FDA listed —
Clindamycin Phosphate and Benzoyl Peroxide 25 mg/g; 10 mg/g 72162-2077-01 Bryant 1 bottle — AB FDA listed —
Acanya 10 mg/g; 25 mg/g 13548-0132-50 Bausch 1 bottle — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2008
First FDA approval
Oct 2008
📍
2026
Currently FDA-listed
18 years listed
🛡️
2029
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 23, 2008 AB TE-rated RLD RS ⏳ ~2.8 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8288434 — method of use (U-818)
US 8288434 — method of use (U-124)
US 8288434 — method of use (U-134)
US 9561208 — method of use (U-916)
US 10220049 — method of use (U-916)
US 9504704 — method of use (U-134)
US 9504704 — method of use (U-818)
US 9504704 — method of use (U-916)
US 8288434 — method of use (U-124)
US 8288434 — method of use (U-1033)
US 8288434 — method of use (U-921)
US 9504704 — method of use (U-124)
US 8288434 — method of use (U-916)
US 8895070 — method of use (U-124)
US 10137142 — method of use (U-916)
US 10220049 — method of use (U-916)
US 10624918 — method of use (U-916)
US 8663699 — method of use (U-124)
US 9078870 — drug product
2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (19)
PatentTypeUse codeExpires
US 8288434 ↗ Method of use U-818 Aug 5, 2029
US 8288434 ↗ Method of use U-124 Aug 5, 2029
US 8288434 ↗ Method of use U-134 Aug 5, 2029
US 9561208 ↗ Method of use U-916 Jun 3, 2029
US 10220049 ↗ Method of use U-916 Jun 3, 2029
US 9504704 ↗ Method of use U-134 Jun 3, 2029
US 9504704 ↗ Method of use U-818 Jun 3, 2029
US 9504704 ↗ Method of use U-916 Jun 3, 2029
US 8288434 ↗ Method of use U-124 Aug 5, 2029
US 8288434 ↗ Method of use U-1033 Aug 5, 2029
US 8288434 ↗ Method of use U-921 Aug 5, 2029
US 9504704 ↗ Method of use U-124 Jun 3, 2029
US 8288434 ↗ Method of use U-916 Aug 5, 2029
US 8895070 ↗ Method of use U-124 Jun 3, 2029
US 10137142 ↗ Method of use U-916 Jun 3, 2029
US 10220049 ↗ Method of use U-916 Jun 3, 2029
US 10624918 ↗ Method of use U-916 Jun 3, 2029
US 8663699 ↗ Method of use U-124 Jun 3, 2029
US 9078870 ↗ Drug product — Jun 3, 2029
Common questions
Is there a generic version of CLIND PH-BENZOYL PERO 1.2-2.5%?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for CLIND PH-BENZOYL PERO 1.2-2.5%. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Clindamycin and Benzoyl Peroxide Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerOceanside Pharmaceuticals
Application holderBAUSCH HEALTH AMERICAS INC
FDA applicationNDA050819 (NDA AUTHORIZED GENERIC)
Labeler code68682
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio87 products on file

More NDCs from Oceanside Pharmaceuticals labeler code 68682

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )

⏱️ Dosage and Administration 143 words ▾

2 DOSAGE AND ADMINISTRATION Before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin.

Use of Clindamycin Phosphate and Benzoyl Peroxide Gel beyond 12 weeks has not been evaluated. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Clindamycin Phosphate and Benzoyl Peroxide Gel is not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel to the face once daily.

( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS Gel, 1.2%/2.5% Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel contains 10 mg (1%) clindamycin as phosphate, and 25 mg (2.5%) benzoyl peroxide in a white to off-white, opaque, smooth gel. Gel, 1.2% clindamycin phosphate/2.5% benzoyl peroxide

⛔ Contraindications 135 words ▾

4 CONTRAINDICATIONS Clindamycin Phosphate and Benzoyl Peroxide Gel is contraindicated in: • Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4.1 ) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4.2 )

4.1Hypersensitivity Clindamycin Phosphate and Benzoyl Peroxide Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with Clindamycin Phosphate and Benzoyl Peroxide Gel [see Postmarketing Experience (6.2) ] .

4.2Colitis/Enteritis Clindamycin Phosphate and Benzoyl Peroxide Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ] .

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS • Colitis: Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. Clindamycin Phosphate and Benzoyl Peroxide Gel should be discontinued if significant diarrhea occurs.

( 5.1 ) • Ultraviolet Light and Environmental Exposure: Minimize sun exposure following drug application. ( 5.2 )

5.1Colitis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. When significant diarrhea occurs, Clindamycin Phosphate and Benzoyl Peroxide Gel should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

5.2Ultraviolet Light and Environmental Exposure Minimize sun exposure including use of tanning beds or sun lamps following drug application.

5.3Concomitant Topical Medications Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of subjects treated with Clindamycin Phosphate and Benzoyl Peroxide Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%).

During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1.

Table 1: Percent of Subjects with Local Skin Reactions. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod. Mod. = Moderate Severe Mild Mod.

Severe Mild Mod. Severe Erythema 22 4 0 25 5 < 1 15 2 0 Scaling 8 < 1 0 18 3 0 8 1 0 Itching 10 2 0 15 2 0 6 < 1 0 Burning 3 < 1 0 8 2 0 2 < 1 0 Stinging 2 < 1 0 6 1 0 1 < 1 0

6.2Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

🔄 Drug Interactions 114 words ▾

7 DRUG INTERACTIONS • Avoid using Clindamycin Phosphate and Benzoyl Peroxide Gel in combination with topical or oral erythromycin-containing products because of its clindamycin component. ( 7.1 )

7.1Erythromycin Clindamycin Phosphate and Benzoyl Peroxide Gel should not be used in combination with topical or oral erythromycin-containing products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

7.2Neuromuscular Blocking Agents Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Clindamycin Phosphate and Benzoyl Peroxide Gel should be used with caution in patients receiving such agents.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on Clindamycin Phosphate and Benzoyl Peroxide Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data) .In limited published clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of major birth defects.

In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times the maximum recommended human dose (MRHD) of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, based on body surface area (BSA) comparisons (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy.

Animal Data Animal reproductive/developmental toxicity studies have not been conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in pregnant rats and mice administered during the period of organogenesis at oral doses of up to 600 mg/kg/day (240 and 120 times the MRHD for, respectively, based on BSA comparisons) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the MRHD for clindamycin, respectively, based on BSA comparisons) revealed no malformations or embryo-fetal development toxicity.

8.2Lactation Risk Summary There are no data on the presence of clindamycin or benzoyl peroxide in human milk, the effects on the breastfed child, or the effects on milk production following topical administration. However, clindamycin has been reported to be present in breast milk in small amounts following oral and parenteral administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Clindamycin Phosphate and Benzoyl Peroxide Gel and any potential adverse effects on the breastfed child from Clindamycin Phosphate and Benzoyl Peroxide Gel or from the underlying maternal condition.

Clinical Considerations If used during lactation and Clindamycin Phosphate and Benzoyl Peroxide Gel is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

8.4Pediatric Use Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel in pediatric patients under the age of 12 have not been evaluated.

8.5Geriatric Use Clinical trials of Clindamycin Phosphate and Benzoyl Peroxide Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on Clindamycin Phosphate and Benzoyl Peroxide Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The limited published data on use of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see Data) .In limited published clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of major birth defects.

In animal reproduction studies, clindamycin did not cause malformations or embryo-fetal development toxicity in pregnant rats and mice when administered during the period of organogenesis at systemic doses up to 240 times the maximum recommended human dose (MRHD) of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, based on body surface area (BSA) comparisons (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data In limited published trials in pregnant women administered clindamycin during the first trimester of pregnancy, there was no difference in the rate of major birth defects reported among in utero exposed infants compared to unexposed infants. These data cannot definitely establish or exclude any clindamycin-associated risk during pregnancy.

Animal Data Animal reproductive/developmental toxicity studies have not been conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in pregnant rats and mice administered during the period of organogenesis at oral doses of up to 600 mg/kg/day (240 and 120 times the MRHD for, respectively, based on BSA comparisons) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the MRHD for clindamycin, respectively, based on BSA comparisons) revealed no malformations or embryo-fetal development toxicity.

🧒 Pediatric Use 25 words ▾

8.4Pediatric Use Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel in pediatric patients under the age of 12 have not been evaluated.

🧓 Geriatric Use 32 words ▾

8.5Geriatric Use Clinical trials of Clindamycin Phosphate and Benzoyl Peroxide Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanisms of Action Clindamycin: Clindamycin is a lincosamide antibacterial [see Microbiology (12.4) ] . Benzoyl Peroxide: Benzoyl peroxide is an oxidizing agent with bactericidal and keratolytic effects but the precise mechanism of action is unknown.

12.3Pharmacokinetics The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of Clindamycin Phosphate and Benzoyl Peroxide Gel applied to the face once daily for 30 days. Twelve subjects (75%) had at least one quantifiable clindamycin plasma concentration above the lower limit of quantification (LOQ = 0.5 ng/mL) on Day 1 or Day 30. On Day 1, the mean (± standard deviation) peak plasma concentration (C max ) was 0.78 ± 0.22 ng/mL (n=9 with measurable concentrations), and the mean AUC 0-t was 5.29 ± 0.81 h.ng/mL (n=4).

On Day 30, the mean C max was 1.22 ± 0.88 ng/mL (n=10), and the mean AUC 0-t was 8.42 ± 6.01 h.ng/mL (n=6). Clindamycin plasma concentrations were below LOQ in all subjects at 24 hours post-dose on the three tested days (Day 1, 15, and 30). Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

12.4Microbiology Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing bacterial protein synthesis. Clindamycin and benzoyl peroxide individually have been shown to havein vitro activity against Propionibacterium acnes , an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes is not known. P. acnes resistance to clindamycin has been documented.

Resistance to clindamycin is often associated with resistance to erythromycin.

📦 How Supplied / Storage and Handling 112 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as: NDC 68682-132-50 50 g pump

16.2Dispensing Instructions for the Pharmacist • Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel with a 10-week expiration date. • Specify "Store at room temperature up to 25°C (77°F). Do not freeze."

16.3Storage and Handling • PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F). • PATIENT: Store at room temperature at or below 25°C (77°F). • Protect from freezing. • Store pump upright. • Keep out of the reach of children. • Keep container tightly closed.

📋 Description 162 words ▾

11 DESCRIPTION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)‑hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate).

The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below: Benzoyl peroxide: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 Clindamycin Phosphate and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water.

Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin. chem1 chem2

💬 Information for Patients 153 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). • Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately. • Clindamycin Phosphate and Benzoyl Peroxide Gel may cause irritation such as erythema, scaling, itching, or burning, especially when used in combination with other topical acne therapies. • Excessive or prolonged exposure to sunlight should be limited.

To minimize exposure to sunlight, a hat or other clothing should be worn. Sunscreen may also be used. • Clindamycin Phosphate and Benzoyl Peroxide Gel may bleach hair or colored fabric. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada U.S.

Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918 © 2020 Bausch Health Companies Inc. or its affiliates 9613801

🧬 Pharmacokinetics 170 words ▾

12.3Pharmacokinetics The systemic absorption of clindamycin was investigated in an open-label, multiple-dose trial in 16 adult subjects with moderate to severe acne vulgaris treated with 1 gram of Clindamycin Phosphate and Benzoyl Peroxide Gel applied to the face once daily for 30 days. Twelve subjects (75%) had at least one quantifiable clindamycin plasma concentration above the lower limit of quantification (LOQ = 0.5 ng/mL) on Day 1 or Day 30. On Day 1, the mean (± standard deviation) peak plasma concentration (C max ) was 0.78 ± 0.22 ng/mL (n=9 with measurable concentrations), and the mean AUC 0-t was 5.29 ± 0.81 h.ng/mL (n=4).

On Day 30, the mean C max was 1.22 ± 0.88 ng/mL (n=10), and the mean AUC 0-t was 8.42 ± 6.01 h.ng/mL (n=6). Clindamycin plasma concentrations were below LOQ in all subjects at 24 hours post-dose on the three tested days (Day 1, 15, and 30). Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of once daily use of Clindamycin Phosphate and Benzoyl Peroxide Gel were assessed in two 12-week multi-center, randomized, blinded trials in subjects 12 years and older with moderate to severe acne vulgaris. The two trials were identical in design and compared Clindamycin Phosphate and Benzoyl Peroxide Gel to clindamycin in the vehicle gel, benzoyl peroxide in the vehicle gel, and the vehicle gel alone. The co-primary efficacy variables were: 1.

Mean absolute change from baseline at Week 12 in: 2. Inflammatory lesion counts 3. Non-inflammatory lesion counts 4.

Percent of subjects who had a 2-grade improvement from baseline on an Evaluator’s Global Severity (EGS) score. The EGS scoring scale used in all of the clinical trials for Clindamycin Phosphate and Benzoyl Peroxide Gel is as follows: Grade Description Clear Normal, clear skin with no evidence of acne vulgaris Almost Clear Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) Mild Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic lesions) Moderate Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one small nodulocystic lesion Severe Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulocystic lesions Very Severe Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions The results of Trial 1 at Week 12 are presented in Table 2: Table 2: Trial 1 Results Clindamycin Phosphate and Benzoyl Peroxide Gel Clindamycin Gel Benzoyl Peroxide Gel Vehicle Gel Trial 1 N = 399 N = 408 N = 406 N = 201 EGSS Clear or Almost Clear 115 (29%) 84 (21%) 76 (19%) 29 (14%) 2-grade reduction from baseline 131 (33%) 100 (25%) 96 (24%) 38 (19%) Inflammatory Lesions: Mean absolute change 14.8 12.2 13.0

9.0Mean percent (%) reduction 55.0% 47.1% 49.3% 34.5% Non-Inflammatory Lesions: Mean absolute change 22.1 17.9 20.6

13.2Mean percent (%) reduction 45.3% 38.0% 40.2% 28.6% The results of Trial 2 at Week 12 are presented in Table 3: Table 3: Trial 2 Results Clindamycin Phosphate and Benzoyl Peroxide Gel Clindamycin Gel Benzoyl Peroxide Gel Vehicle Gel Trial 2 N = 398 N = 404 N = 403 N = 194 EGSS Clear or Almost Clear 113 (28%) 94 (23%) 94 (23%) 21 (11%) 2-grade reduction from baseline 147 (37%) 114 (28%) 114 (28%) 27 (14%) Inflammatory Lesions: Mean absolute change 13.7 11.3 11.2

5.7Mean percent (%) reduction 54.2% 45.3% 45.7% 23.3% Non-Inflammatory Lesions: Mean absolute change 19.0 14.9 15.2

8.3Mean percent (%) reduction 41.2% 34.3% 34.5% 19.2%

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and impairment of fertility testing of Clindamycin Phosphate and Benzoyl Peroxide Gel have not been performed. Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice.

The clinical significance of this is unknown. Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times the MRHD forclindamycin and 3.6, 10.8, and 60 times the MRHD forbenzoyl peroxide, respectively, based on BSA comparisons) did not cause any increase in tumors.

However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900, and 3000 mg/kg/day (1.2, 3.6, and 12 times the MRHD for clindamycin and 2.4, 7.2, and 24 times the MRHD for benzoyl peroxide, respectively, based on BSA comparisons) for up to 97 weeks did not cause any increase in tumors.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with Clindamycin Phosphate and Benzoyl Peroxide Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin.

Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the MRHD for clindamycin, based on BSA comparisons) revealed no effects on fertility or mating ability.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and impairment of fertility testing of Clindamycin Phosphate and Benzoyl Peroxide Gel have not been performed. Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice.

The clinical significance of this is unknown. Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times the MRHD forclindamycin and 3.6, 10.8, and 60 times the MRHD forbenzoyl peroxide, respectively, based on BSA comparisons) did not cause any increase in tumors.

However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900, and 3000 mg/kg/day (1.2, 3.6, and 12 times the MRHD for clindamycin and 2.4, 7.2, and 24 times the MRHD for benzoyl peroxide, respectively, based on BSA comparisons) for up to 97 weeks did not cause any increase in tumors.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells. Fertility studies have not been performed with Clindamycin Phosphate and Benzoyl Peroxide Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin.

Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the MRHD for clindamycin, based on BSA comparisons) revealed no effects on fertility or mating ability.

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert PATIENT INFORMATION Clindamycin Phosphate and Benzoyl Peroxide gel, 1.2%/2.5% Important information: Clindamycin Phosphate and Benzoyl Peroxide Gel is for use on skin only (topical use) . Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel in your mouth, eyes, or vagina. What is Clindamycin Phosphate and Benzoyl Peroxide Gel?

Clindamycin Phosphate and Benzoyl Peroxide Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel is safe and effective for use longer than 12 weeks. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel is safe and effective in children under 12 years of age.

Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel if you have: • had an allergic reaction to clindamycin, benzoyl peroxide, lincomycin or any of the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel. See the end of this leaflet for a complete list of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel. • Crohn’s disease or ulcerative colitis. • had inflammation of the colon (colitis), or severe diarrhea with past antibiotic use. • Talk with your doctor if you are not sure if you have any of the conditions listed above.

Before using Clindamycin Phosphate and Benzoyl Peroxide Gel, tell your doctor about all of your medical conditions, including if you: • plan to have surgery. Clindamycin Phosphate and Benzoyl Peroxide Gel may affect how certain medicines work that may be given during surgery. • are pregnant or plan to become pregnant. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel will harm your unborn baby. • are breastfeeding or plan to breastfeed.

It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel passes into your breast milk. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. Talk to your doctor about the best way to feed your baby during treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Clindamycin Phosphate and Benzoyl Peroxide Gel may affect the way other medicines work and other medicines may affect how Clindamycin Phosphate and Benzoyl Peroxide Gel works. • Especially tell your doctor if you take medicine by mouth that contains erythromycin or use products on your skin that contain erythromycin. Clindamycin Phosphate and Benzoyl Peroxide Gel should not be used with products that contain erythromycin. • Tell your doctor about any skin products you use.

Other skin and topical acne products may increase the irritation of your skin when used with Clindamycin Phosphate and Benzoyl Peroxide Gel. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I use Clindamycin Phosphate and Benzoyl Peroxide Gel? • Use Clindamycin Phosphate and Benzoyl Peroxide Gel exactly as your doctor tells you to use it. See the detailed “Instructions for Use” for directions about how to apply Clindamycin Phosphate and Benzoyl Peroxide Gel. • Your doctor will tell you how long to use Clindamycin Phosphate and Benzoyl Peroxide Gel. • Apply Clindamycin Phosphate and Benzoyl Peroxide Gel to your face 1 time each day. What should I avoid while using Clindamycin Phosphate and Benzoyl Peroxide Gel? • Limit your time in sunlight.

You should avoid using tanning beds or sunlamps during treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing, and use sunscreen to cover the treated areas. • Avoid getting Clindamycin Phosphate and Benzoyl Peroxide Gel in your hair or on colored fabric. Clindamycin Phosphate and Benzoyl Peroxide Gel may bleach hair or colored fabric.

What are possible side effects of C… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~2 min read ▾

Instructions for Use INSTRUCTIONS FOR USE Clindamycin Phosphate and Benzoyl Peroxide gel, 1.2%/2.5% Important Information: Clindamycin Phosphate and Benzoyl Peroxide Gel is for use on skin only (topical use). Clindamycin Phosphate and Benzoyl Peroxide Gel is not for use in your mouth, eyes or vagina. Read this Instructions for Use before you start using Clindamycin Phosphate and Benzoyl Peroxide Gel and each time you get a refill.

There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. • Apply Clindamycin Phosphate and Benzoyl Peroxide Gel to your face 1 time each day as prescribed. • Before you apply Clindamycin Phosphate and Benzoyl Peroxide Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. • To apply Clindamycin Phosphate and Benzoyl Peroxide Gel to your face, use the pump to dispense one pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel onto your fingertip.

See Figure 1. • One pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel should be enough to cover your entire face. Figure 1 • Dot the one pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel onto six areas of your face (chin, left cheek, right cheek, nose, left forehead, right forehead). See Figure 2.

Figure 2 • Spread the gel over your face and gently rub it in. It is important to spread the gel over your entire face. If your doctor tells you to put Clindamycin Phosphate and Benzoyl Peroxide Gel on other areas of your skin with acne, be sure to ask how much you should use. • Wash your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel.

How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel? • Store Clindamycin Phosphate and Benzoyl Peroxide Gel at room temperature at or below 77°F (25°C). • Do not freeze Clindamycin Phosphate and Benzoyl Peroxide Gel. • Throw away (discard) Clindamycin Phosphate and Benzoyl Peroxide Gel that has passed the expiration date. • Store pump upright. • Keep the container tightly closed. Keep Clindamycin Phosphate and Benzoyl Peroxide Gel and all medicines out of the reach of children. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada U.S.

Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918 © 2020 Bausch Health Companies Inc. or its affiliates The Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Issued: 09/2020 9613801 figure1 figure2

📄 Package Label / Principal Display Panel 26 words ▾

Package/Label Display Panel NDC 68682-132-50 Rx only Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% FOR TOPICAL USE ONLY One premixed 50-gram pump dispenser OCEANSIDE Pharmaceuticals carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Clindamycin Phosphate and Benzoyl Peroxide — the ingredient across all brands.

Top reported reactions

Erythema26
Acne25
Pruritus25
Rash22
Dry Skin18
Expired Product Administered16
Skin Discolouration13

Age at onset

Child1
Adolescent4
Adult23

Reporter sex

315 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization19
Disabling3
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 22 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 68682-0113-20 · Oceanside 68682-0133-50 · Oceanside →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.