HomeNDC LookupIngredientsBenzoyl Peroxide › 45802-0318-34
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(from DailyMed)

benzoyl peroxide 10 g/100g Suspension, 227 g

by Padagis Israel Pharmaceuticals Ltd · 227 g in 1 BOTTLE (45802-318-34)
NDC 45802-0318-34
🏷️ FDA NDC (as labeled) 45802-318-34 billing pads the product segment with a zero
This package
Contains227 g Cost per g$0.0443 NADAC Per package$10.06 / 227 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0608/unit — full pricing hub ↓
Also comes in: 142 g 45802-0318-01
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 45802-318-34
Product NDC 45802-318
11-digit billing NDC 45802031834
NCPDP billing unit GM — per gram (weight)
RxCUI 142034
UNII W9WZN9A0GM
Application # M006
SPL Set ID 8730957f-f051-4aa5-b5ab-3186051b3789
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2013-02-20
Marketing end 2026-07-31
Route TOPICAL
Dosage form SUSPENSION
Substance BENZOYL PEROXIDE
GPI-14 90050010000910
GPI class Benzoyl Peroxide Wash
GCN Seq No 059137
GCN 24673
HICL code 002470
Ingredient (HICL) Benzoyl Peroxide
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name BENZOYL PEROXIDE 10% WASH
FDB brand name Benzoyl Peroxide
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 45802-318-34 — 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 → 45802-0318-34. 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.

🏭 Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code45802
First marketedFeb 2013
Product typeHuman Otc Drug
Portfolio175 products on file
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.

🩺 Clinical

Label name BENZOYL PEROXIDE 10% WASH Ingredient Benzoyl Peroxide
📖 What it is MedlinePlus · NLM

Benzoyl peroxide is used to treat mild to moderate acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most benzoyl peroxide products are used to treat acne — they clear up pimples, blemishes, blackheads, and whiteheads, and help keep new ones from forming. One prescription product,...
  • What exactly is benzoyl peroxide used for?
  • Yes, some dryness, redness, peeling, and mild irritation are very common, especially when you first start. The best strategy is to begin with just once daily and slowly work up to...
  • My skin got really dry and red after I started using it — is that normal?
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 $0.044 $10.06 / 227 g
Medicaid paysCMS SDUD · 12 mo $0.0608 $13.80 / 227 g
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 $0.051 $0.043
▼ Down 13% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
benzoyl peroxide 10 g/100gthis 45802-0318-34 Padagis 227 g $0.044 Discontinued
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 Rugby 237 g $0.046 Discontinued +4%
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 Rugby 237 g $0.046 Availability likely +4%
Benzoyl Peroxide 100 mg/mL 35573-0454-08 Burel 237 ml $0.046 Availability likely +4%
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/mL 00536-1261-63 Rugby 148 ml $0.047 Availability likely +6%
Differin Max Strength Acne Foaming BPO Cleanser 10 g/100mL 00299-4137-00 Galderma 1 tube FDA listed
PanOxyl 100 mg/g 00316-0228-01 Crown 1 tube Discontinued
Walgreens Acne Foaming Wash Acne Medication 100 mg/g 00363-1522-01 Walgreen 156 g FDA listed
Walgreens Acne Control Cleanser Acne Medication 100 mg/g 00363-3602-01 Walgreen 142 g FDA listed
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/mL 10742-1202-01 The 148 ml FDA listed
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/g 10742-1206-01 The 3 g FDA listed
OXY 10 Acne Cleanser 100 mg/mL 10742-1397-01 The 148 ml FDA listed
BP Wash 100 mg/g 24470-0901-05 CINTEX 142 g Discontinued
Acne Cleanser 100 mg/g 41250-0264-56 Meijer, 141 g FDA listed
Acne Cleanser 100 mg/g 49035-0264-56 Walmart, 141 g FDA listed
CeraVe Acne Foaming CreamWash 100 mg/mL 49967-0604-01 L'Oreal 1 tube Discontinued
Replenix Acne Solutions Wash 100 mg/mL 51326-0112-01 Topiderm, 200 ml FDA listed
Replenix Acne 10% Wash Paraben Free With Aloe 100 mg/mL 51326-0113-01 Topiderm, 200 ml FDA listed
Dr. Zenovia Acne Cleanser 100 mg/mL 51326-0803-01 Topiderm, 1 bottle FDA listed
humane acne wash 100 mg/mL 69919-0021-01 Banner 1 tube FDA listed
HUMANE Maximum Strength Acne Wash 10 Benzoyl Peroxide 100 mg/mL 69919-0527-08 Banner 1 bottle FDA listed
MEDPURA Benzoyl Peroxide 100 mg/mL 71399-9236-05 Akron 148 ml FDA listed
benzoyl peroxide 10 g/100g 72162-2337-02 Bryant 142 g FDA listed
Daily Acne Control Cleanser 100 mg/g 72288-0264-56 Amazon.com 141 g FDA listed
Humane Acne Wash 100 mg/mL 73010-0900-00 Apprendista, 237 ml FDA listed
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 75376-0474-42 Guangzhou 237 g FDA listed
Daily Acne Control Cleanser 100 mg/g 76162-0264-28 Topco 141 g FDA listed
Meijer Maximum Strength Foaming Acne Face Wash Acne Medication 100 mg/g 79481-0022-01 Meijer 1 tube FDA listed
Equate Acne Wash Acne medication 100 mg/g 79903-0061-01 Wal-Mart 1 tube FDA listed
Benzoyl Peroxide Deep Cleansing Foaming Wash .1 g/g 80861-0112-01 AcneFree, 1 g FDA listed
BENZOYL PEROXIDE 10% Topical wash 100 mg/mL 82461-0313-05 Medcore 148 ml FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 45802-0318-34, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.6K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$75.1K
Avg / prescription
$13.47
Avg / unit
$0.0608
Latest quarter Q4 2025
440Rx
Medicaid pays / g
$0.0608
gross reimbursed
vs
NADAC / g
$0.0443
acquisition cost
=
Spread
+$0.0165
+37% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
41% FFS 59% MCO
Fee-for-service · 2,264 Rx Managed care · 3,310 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 15,683 units · 273 per 100k residents MN Wisconsin: 31,578 units · 534 per 100k residents WI Michigan: 138,046 units · 1,375 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 4,096 units · 96.8 per 100k residents OR Nevada: 4,777 units · 150 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 9,080 units · 283 per 100k residents IA Illinois: 15,022 units · 120 per 100k residents IL Indiana: 15,419 units · 225 per 100k residents IN Ohio: 82,855 units · 703 per 100k residents OH Pennsylvania: 112,819 units · 870 per 100k residents PA New Jersey: 35,604 units · 383 per 100k residents NJ Massachusetts: 24,915 units · 356 per 100k residents MA California: 369,344 units · 948 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 13,737 units · 694 per 100k residents NE Missouri: no data reported MO Kentucky: 39,682 units · 877 per 100k residents KY West Virginia: 34,958 units · 1,975 per 100k residents WV Virginia: 9,499 units · 109 per 100k residents VA Maryland: 23,509 units · 380 per 100k residents MD Connecticut: 46,762 units · 1,293 per 100k residents CT Rhode Island: 6,064 units · 554 per 100k residents RI Arizona: 33,690 units · 453 per 100k residents AZ New Mexico: 6,830 units · 323 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 14,467 units · 203 per 100k residents TN North Carolina: no data reported NC South Carolina: 9,554 units · 178 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 5,241 units · 178 per 100k residents MS Alabama: no data reported AL Georgia: 54,184 units · 491 per 100k residents GA D.C.: 4,104 units · 604 per 100k residents DC Hawaii: 8,626 units · 601 per 100k residents HI Texas: 64,221 units · 211 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
96.81,975
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 1,975 /100k
2 Michigan 1,375 /100k
3 Connecticut 1,293 /100k
4 California 948 /100k
5 Kentucky 877 /100k
6 Pennsylvania 870 /100k
7 Ohio 703 /100k
8 Nebraska 694 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
142 gs45802-0318-01 8,562 Rx · $100,379
227 gs this page45802-0318-34 5,574 Rx · $75,055
Drug total (last 4 qtrs): 14,136 Rx · 2,471,105 units · $175,434 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epsolay. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 BENZOYL PEROXIDE — the ingredient across all brands.

Top reported reactions

Dry Skin1,617
Acne1,576
Erythema1,296
Skin Burning Sensation1,081
Skin Irritation927
Skin Exfoliation620
Pruritus589

Age at onset

Neonate1
Infant1
Child5
Adolescent71
Adult260
Elderly30

Reporter sex

7,972 reports
Male · 23%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization473
Life-threatening139
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,050 119
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
45802-0318-01 142 g in 1 BOTTLE (45802-318-01) $0.0475 / g $6.75 2013-02-20 Discontinued by firm
45802-0318-34 You're viewing this 227 g in 1 BOTTLE (45802-318-34) $0.0443 / g $10.05 2013-02-20 Discontinued by firm

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.0443 NADAC).

This pack accounts for about 39% of this product's recent Medicaid fills; most go to the 142 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 45802-0318-34?
NDC 45802-0318-34 contains 227 g — 227 g in 1 bottle.
What is the difference between NDC 45802-0318-34 and NDC 45802-0318-01?
Both are benzoyl peroxide 10 g/100g Suspension — the drug itself is identical. NDC 45802-0318-34 is the 227 g package, while NDC 45802-0318-01 is the 142 g package. Per-g NADAC also differs: $0.0443 here vs $0.0475 for the 142 g pack.
What NDC number is used to bill for this package of benzoyl peroxide 10 g/100g Suspension?
Bill NDC 45802-0318-34 — the 11-digit billing format is 45802031834. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 45802-318-34, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 45802-0318-34, written without dashes as 45802031834. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 45802-0318-34, the first segment (45802) is the labeler code FDA assigned to Padagis Israel Pharmaceuticals Ltd; the middle segment (0318) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (34) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 142 g (45802-0318-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Padagis Israel Pharmaceuticals Ltd is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 6 words

Use for the treatment of acne

⏱️ Dosage and Administration 131 words

Directions • shake well • Sensitivity Test for a New User . Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. • wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day • if going outside, apply sunscreen after using this product.

If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 151 words

Warnings For external use only Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide When using this product • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.

Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if • irritation becomes severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

(1-800-222-1222)

🧪 Active Ingredient 5 words

Active ingredient Benzoyl peroxide 10%

🧪 Inactive Ingredients 26 words

Inactive ingredients carbomer homopolymer, citric acid*, edetate disodium, glycerin, imidurea, lauryl methacrylate/glycol dimethacrylate crosspolymer, purified water, sodium C14-16 olefin sulfonate, sodium hydroxide *may contain this ingredient

🎯 Purpose 3 words

Purpose Acne medication

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