FDA-filed SPL labeling · retrieved through openFDA

Clindamycin / Tretinoin

Clindamycin / tretinoin is a combination antibiotic and retinoid gel used to treat acne vulgaris in people 12 years and older.

Brand names ZianaVeltin
Drug class Retinoid
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 18, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 1, 2020
Clinical labels in scope 5
AvailabilityRx
Earliest approval/marketing year 2006
FDA-listed product records 11
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Clindamycin / Tretinoin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Clindamycin / tretinoin gel is a proven combination treatment for acne vulgaris in patients 12 and older, targeting bacteria and clogged pores at the same time. Apply just a pea-sized amount at bedtime, protect your skin from the sun daily, and watch for any signs of serious stomach symptoms like bloody or severe diarrhea. Use it exactly as directed and follow up with your prescriber to make sure it's working safely for you.

📖 Clindamycin / Tretinoin: Patient Information Guide

A plain-language walkthrough of Clindamycin / Tretinoin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Clindamycin / tretinoin gel is an antibiotic-retinoid combination used to treat acne on the skin. All supported products are approved for the same indication:

  • Treatment of acne vulgaris (common acne) in patients 12 years of age and older — supported by Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel, Clindamycin Phosphate and Tretinoin Gel, Veltin Gel, and Ziana Gel
⚙️How it works

This gel works through two different pathways at once. Clindamycin is an antibiotic that binds to a part of bacterial cells called the 50S ribosomal subunit, blocking bacteria — particularly Propionibacterium acnes, the main acne-linked bacterium — from making proteins they need to grow. Tretinoin, a retinoid, speeds up the natural turnover of skin cells lining the hair follicles, making it harder for pores to get plugged. It also reduces the stickiness of those cells so that existing plugs (comedones) are pushed out more easily.

One important note: bacteria can develop resistance to clindamycin over time — and resistance to clindamycin often goes hand in hand with resistance to erythromycin. This is why this gel should not be combined with erythromycin products, and why it should only be used for as long as prescribed.

💊How it's taken

All forms of clindamycin / tretinoin gel are applied to the face once daily in the evening or at bedtime. Use only a pea-sized amount — that's enough to cover the whole face. Gently spread it across the affected area and keep it well away from your eyes, mouth, the corners of your nose, lips, and mucous membranes. This is a topical gel only — do not take it by mouth, use it in your eyes, or use it vaginally.

  • Veltin Gel: apply once daily in the evening, lightly covering the entire affected area
  • Ziana Gel and Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel: apply once daily at bedtime, dotting onto chin, cheeks, nose, and forehead, then gently rubbing over the entire face
🤒Side effects — in detail

The most common side effects are local skin reactions at the application site. These include:

  • Skin redness (erythema)
  • Peeling or scaling
  • Itching
  • Burning or stinging
  • Dry skin
  • Nasopharyngitis (cold-like symptoms such as a runny or stuffy nose)
  • Pharyngolaryngeal pain (sore throat)
  • Cough

Seek medical attention right away if you develop severe, persistent, or bloody diarrhea, or bad stomach cramps — these could be signs of serious colitis (colon inflammation), which can be life-threatening.

⚠️Warnings & precautions
  • Serious colitis risk: Clindamycin — even applied to skin — can be absorbed into the body and has been linked to severe colon inflammation, including pseudomembranous colitis caused by Clostridium difficile. Stop the gel and call your doctor immediately if you have significant diarrhea, bloody diarrhea, or severe stomach cramps. Do not use anti-diarrhea medicines without medical advice — they can make this condition worse or last longer. Severe colitis can be fatal.
  • Sun sensitivity: Tretinoin makes your skin much more sensitive to ultraviolet light. Avoid sunlight, sunlamps, and tanning beds while using this gel. Apply sunscreen and wear protective clothing (like a hat) every day. Do not use the gel on sunburned skin — wait until the burn has fully healed. Wind and cold weather can also irritate skin that is being treated.
  • Antibiotic resistance: Using clindamycin over time may cause bacteria on your skin to become resistant to it and to related antibiotics like erythromycin. Use only as long as prescribed.
🔀What it interacts with

Tell your doctor and pharmacist about all products you use on your skin and any medicines you take. Key interactions to know:

  • Erythromycin-containing products: Do not use alongside this gel — the two antibiotics work against each other and the combination reduces effectiveness
  • Harsh or drying topical products: Medicated or abrasive soaps, astringents, products with high alcohol content, and heavily drying cleansers or cosmetics can increase skin irritation when used at the same time — use with caution
  • Neuromuscular blocking agents (muscle-relaxing medicines used in medical procedures): Clindamycin can strengthen their muscle-relaxing effects — tell your doctor or anesthesiologist that you use this gel

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have regional enteritis (Crohn's disease affecting the intestines), ulcerative colitis, or a past history of antibiotic-associated colitis — these are contraindications
  • If you are pregnant or thinking about becoming pregnant, talk to your doctor first — oral tretinoin is known to cause birth defects in animals; while systemic absorption from this topical gel is minimal, the risk to a human fetus is not fully established
  • If you are breastfeeding, discuss with your doctor — clindamycin given by mouth or injection has been found in breast milk; it is unknown whether it passes into milk from topical use
  • Not for use in children under 12 years old — safety and effectiveness have not been established in this age group
  • Older adults (65+) were not studied in sufficient numbers to know if they respond differently — talk to your prescriber
  • If your job or lifestyle means you spend a lot of time outdoors in the sun, let your doctor know — extra sun protection will be essential
🔬Pharmacokinetics — how your body processes it

Studies show that very little of either ingredient is absorbed into the bloodstream when this gel is applied to the skin as directed. In one study, blood levels of tretinoin after 14 days of daily use were minimal, with undetectable levels in up to 92% of subjects at any given time point. Clindamycin plasma concentrations generally stayed at or below 3.5 ng/mL in most subjects, though one individual reached 13.1 ng/mL. Because absorption is so low, systemic (whole-body) effects are unlikely at normal doses — but the possibility of some absorption is why warnings about colitis still apply.

📦How to store it

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from light. Protect from freezing.

📄 Written from Clindamycin / Tretinoin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Clindamycin / Tretinoin — the kind of thing our pharmacy team would talk through with you at the counter.

What is this gel actually supposed to do for my acne?
It targets acne from two directions at once. The clindamycin in it is an antibiotic that fights the bacteria linked to acne breakouts, while tretinoin helps unclog your pores by speeding up how fast your skin cells turn over. Together, they help reduce both existing pimples and the conditions that cause new ones to form. It's approved for people 12 and older with acne vulgaris — the most common type of acne.
How and when should I apply it?
Apply it once a day at bedtime (or in the evening for Veltin). Squeeze out a pea-sized amount — that's really all you need — dot it onto your chin, cheeks, nose, and forehead, then gently spread it over your whole face. Keep it away from your eyes, mouth, the corners of your nose, and lips. Don't use it by mouth, in your eyes, or anywhere other than your skin.
My skin is red and peeling — is that normal?
Yes, that's very common when you first start, especially with the tretinoin component. Redness, dryness, peeling, itching, and a mild burning or stinging feeling are all reported side effects. They often settle down as your skin adjusts. If irritation is severe or doesn't improve, check in with your doctor — they may have tips to help, like adjusting how often you apply it.
Do I really need to wear sunscreen every day?
Absolutely — this is one of the most important things to know. Tretinoin makes your skin significantly more sensitive to sunlight, so you'll burn more easily and irritation can get much worse with sun exposure. Use a broad-spectrum sunscreen every single day, wear a hat if you'll be outside, and avoid tanning beds altogether while using this gel. If you already have a sunburn, wait until it's fully healed before applying the gel again.
I've heard diarrhea can be a sign of something serious — should I be worried?
It's worth taking seriously. Even though this is a topical gel, small amounts of clindamycin can be absorbed through the skin, and clindamycin is linked to a serious type of colon inflammation called colitis. If you develop severe or persistent diarrhea, bloody diarrhea, or bad stomach cramps, stop using the gel and call your doctor right away. Don't take over-the-counter anti-diarrhea medicines first — they can actually make this type of colitis worse.
Can I use this if I'm pregnant or breastfeeding?
Talk to your doctor before using it. Oral tretinoin is known to cause birth defects in animals, and while very little of the tretinoin in this gel is absorbed through the skin, the full risk to a developing baby hasn't been established. If you're breastfeeding, the same caution applies for clindamycin — it has been found in breast milk when taken by mouth. Your doctor can help weigh the benefits and risks for your specific situation.
Is Clindamycin / Tretinoin available over the counter?
Clindamycin / Tretinoin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Clindamycin / Tretinoin first available?
Clindamycin / Tretinoin has been available in the United States since at least 2006, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Clindamycin / Tretinoin?
Clindamycin / Tretinoin is supplied by 6 manufacturers listed in the FDA NDC Directory, including Solaris Pharma Corporation, Actavis Pharma, Inc., Oceanside Pharmaceuticals.

💬 Answers drafted from Clindamycin / Tretinoin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Clindamycin / Tretinoin comes

Clindamycin / Tretinoin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Veltin Ziana
How this form is used
What it may be used for
  • Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older
  • Veltin Gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older
  • Ziana Gel is indicated for the topical treatment of acne vulgaris in patients 12 years and older
Important instructions
  • Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel: apply a pea-sized amount to the entire face once daily at bedtime; dot onto chin, cheeks, nose, and forehead, then gently rub over the entire face
  • Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel: keep away from the eyes, mouth, angles of the nose, and mucous membranes
  • Veltin Gel: apply a pea-sized amount once daily in the evening, gently rubbing to lightly cover the entire affected area; avoid the eyes, lips, and mucous membranes
  • Ziana Gel: apply a pea-sized amount to the entire face once daily at bedtime; keep away from the eyes, mouth, angles of the nose, and mucous membranes
Available strengths 2 strengths
11 FDA-listed product records

📊 Clindamycin / Tretinoin across the U.S. market

How Clindamycin / Tretinoin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
6
Manufacturers
5
Brand names
11
FDA-listed product records
2006
First marketed
Solaris Pharma Corporation27%
Actavis Pharma, Inc.18%
Oceanside Pharmaceuticals18%
Bausch Health US, LLC18%
Almirall, LLC9%
Prasco Laboratories9%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Clindamycin / Tretinoin is used

A general measure of how commonly Clindamycin / Tretinoin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Clindamycin / Tretinoin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,090
Medicaid prescriptions filled (Q1–Q4 2025)
$1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Clindamycin / Tretinoin prescribed? Of the 1,596 medications we measure, Clindamycin / Tretinoin ranks #1,120 by Medicaid prescriptions — more than 30% of them.

Where Clindamycin / Tretinoin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Clindamycin / Tretinoin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

clindamycin phosphate 0.012 MG/MG / tretinoin 0.00025 MG/MG Topical Gel

3,090 Medicaid prescriptions (Q1–Q4 2025) 100% of Clindamycin / Tretinoin prescriptions shown $1M gross reimbursement (before rebates) ≈ $336 per prescription (gross)

Summed across the 10 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 882548

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Clindamycin / Tretinoin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 12 listed Clindamycin / Tretinoin NDCs with Medicaid activity.

🔍 Compare Clindamycin / Tretinoin products

A representative set of FDA-listed product records for Clindamycin / Tretinoin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Topical cream, ointment or gel
CLINDAMYCIN PHOSPHATE 12 mg/g; TRETINOIN 0.25 mg/g Topical Actavis Pharma, Inc. ANDA View NDC →
12; 0.25 mg/g; mg/g Topical Actavis Pharma, Inc. ANDA View NDC →
10; 0.25 mg/g; mg/g Topical Almirall, LLC NDA View NDC →
CLINDAMYCIN PHOSPHATE 12 mg/g; TRETINOIN 0.25 mg/g Topical Bausch Health US, LLC NDA View NDC →
12; 0.25 mg/g; mg/g Topical Bausch Health US, LLC NDA View NDC →
CLINDAMYCIN PHOSPHATE 12 mg/g; TRETINOIN 0.25 mg/g Topical Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC View NDC →
12; 0.25 mg/g; mg/g Topical Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC View NDC →
10; 0.25 mg/g; mg/g Topical Prasco Laboratories NDA AUTHORIZED GENERIC View NDC →
CLINDAMYCIN PHOSPHATE 10 mg/g; TRETINOIN 0.25 mg/g Topical Solaris Pharma Corporation ANDA View NDC →
10; 0.25 mg/g; mg/g Topical Solaris Pharma Corporation × 2 listings ANDA View NDC →

Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Clindamycin / Tretinoin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Clindamycin / Tretinoin RxCUI 687144 1 dose form · 1 strength

Look up RxCUI 687144 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Ziana Veltin

🏭 Manufacturers & labelers

Solaris Pharma Corporation 3 Actavis Pharma, Inc. 2 Oceanside Pharmaceuticals 2 Bausch Health US, LLC 2 Almirall, LLC 1 Prasco Laboratories 1

RxNorm drug class

Clindamycin / Tretinoin belongs to the Retinoid class.

Pharmacologic class Retinoid
Drug family (ATC) Retinoids for topical use in acne, Retinoids for cancer treatment

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 1, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Clindamycin / Tretinoin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Clindamycin / Tretinoin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
5
NDC products indexed
11
Distinct labelers/manufacturers represented
6
Linked representative label
Oceanside Pharmaceuticals
Linked label effective
Apr 1, 2020
Composite sections available
21
Linked SPL Set ID
63b2e85d-8fe5-4f18-9e85-8492c49a7520
Linked SPL Document ID
282973c6-50ee-441b-ab65-52bb582bf30c
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Oceanside Pharmaceuticals is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.