Benzoyl Peroxide / Tretinoin
Benzoyl peroxide / tretinoin is a combination topical treatment used for acne vulgaris in adults and children 9 and older.
🧬 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 2 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 →
📖 Benzoyl Peroxide / Tretinoin: Patient Information Guide
A plain-language walkthrough of Benzoyl Peroxide / 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▾
Benzoyl peroxide / tretinoin is a combination topical treatment. Based on the available product evidence:
- Twyneo cream is approved for the topical treatment of acne vulgaris (common acne) in adults and in children aged 9 years and older.
⚙️How it works▾
Twyneo works through two complementary mechanisms. Benzoyl peroxide is an oxidizing agent — it kills acne-causing bacteria on the skin and helps remove dead skin cells (a keratolytic effect). Tretinoin, a derivative of vitamin A, binds to receptors inside skin cells that control how they grow and mature. This speeds up the turnover of cells lining the pores, which helps prevent tiny clogged pores (microcomedones) from forming and helps push out existing blackheads and whiteheads (comedones). Together, these actions target both the bacterial and the pore-clogging causes of acne.
💊How it's taken▾
Twyneo cream is applied once daily to the skin. Put a thin layer on clean, dry skin over the affected areas, then wash your hands. Avoid getting it on your eyes, lips, the creases beside your nose, or inside any body cavity — it is for external skin use only.
- Apply once daily in the evening or as directed by your prescriber.
- Make sure skin is clean and fully dry before applying.
- If you miss a dose, skip it and apply your next dose at the usual time — do not double up.
🤒Side effects — in detail▾
The most common side effects with Twyneo are at the site where you apply it:
- Pain, stinging, or burning
- Dryness
- Peeling or flaking (exfoliation)
- Redness (erythema)
- Skin inflammation (dermatitis)
- Itching (pruritus)
- Irritation
These reactions are most noticeable in the first two weeks and tend to improve with continued use. Seek emergency care immediately if you experience swelling of the face or throat, hives, or difficulty breathing — these may be signs of a serious allergic reaction (anaphylaxis or angioedema).
⚠️Warnings & precautions▾
- Sun sensitivity: Twyneo makes skin more sensitive to UV light. Limit sun exposure, avoid tanning beds, use sunscreen, and wear protective clothing. Stop using Twyneo at the first sign of sunburn.
- Skin irritation: Dryness, peeling, and redness are common. Avoid applying to cuts, scrapes, eczema-affected, or sunburned skin. If irritation is severe, contact your doctor — you may need to use it less often or add a moisturizer.
- Serious allergic reactions: Rare but reported — including anaphylaxis (life-threatening allergic reaction), angioedema (deep skin swelling), and hives. Stop use immediately and get emergency help if these occur.
🔀What it interacts with▾
The Twyneo label does not identify specific drug, food, or supplement interactions. However, given the skin-sensitizing effects of both ingredients, talk to your doctor or pharmacist before combining it with other topical acne or skin products.
- Sun and UV exposure: Twyneo increases sensitivity to sunlight and artificial UV sources (tanning beds), raising the risk of sunburn — minimize exposure and use sunscreen.
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▾
- Benzoyl peroxide allergy: Do not use Twyneo if you have ever had a serious allergic reaction to benzoyl peroxide or any other ingredient in the product.
- Pregnancy: Tell your doctor if you are pregnant or trying to conceive. Animal studies with tretinoin showed birth defects at high doses; while human studies with topical tretinoin have not confirmed a clear risk, caution is advised. There are no specific data on Twyneo use in pregnancy.
- Breastfeeding: It is not known whether tretinoin or benzoyl peroxide from topical use passes into breast milk. Discuss the risks and benefits with your doctor.
- Children under 9: Safety and effectiveness have not been established in patients younger than 9 years of age.
- Adults 65 and older: Clinical trials included too few older adults to determine if they respond differently — use with guidance from your prescriber.
- Damaged or inflamed skin: Avoid applying to cuts, abrasions, eczematous, or sunburned skin.
🔬Pharmacokinetics — how your body processes it▾
Benzoyl peroxide is absorbed through the skin, where it is converted to benzoic acid and eliminated in the urine. Tretinoin and its metabolites were measured in the bloodstream in a study of 35 patients aged 9 and older who applied Twyneo once daily for 14 days. Detectable levels were found, but they remained low across all age groups studied (adults, teens, and children aged 9–11). These findings suggest that while some systemic absorption of tretinoin does occur with regular use, the amounts entering the bloodstream are small.
📦How to store it▾
Prior to Dispensing: Store TWYNEO between 2ºC to 8ºC (36ºF to 46ºF) until dispensed to the patient. Store TWYNEO at room temperature between 20ºC to 25ºC (68ºF to 77ºF). Do not freeze.
📄 Written from Benzoyl Peroxide / 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 Benzoyl Peroxide / Tretinoin — the kind of thing our pharmacy team would talk through with you at the counter.
What is Twyneo actually for? ▾
My skin got really red and dry when I started using it — is that normal? ▾
Do I need to worry about sun exposure while using this? ▾
Can I use Twyneo if I'm pregnant or breastfeeding? ▾
Is there a right way to apply it? ▾
What should I watch out for that would mean I need to call a doctor right away? ▾
Is Benzoyl Peroxide / Tretinoin available over the counter? ▾
When was Benzoyl Peroxide / Tretinoin first available? ▾
Who makes Benzoyl Peroxide / Tretinoin? ▾
💬 Answers drafted from Benzoyl Peroxide / 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 Benzoyl Peroxide / Tretinoin comes
Benzoyl Peroxide / 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
How this form is used
- Twyneo cream is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older
- Twyneo: Apply a thin layer to the affected areas once daily on clean and dry skin
- Twyneo: Avoid contact with the eyes, lips, paranasal creases (skin folds beside the nose), and mucous membranes
- Twyneo: Wash hands thoroughly after each application
- Twyneo: For skin use only — not for oral, eye, or vaginal use
📊 Benzoyl Peroxide / Tretinoin across the U.S. market
How Benzoyl Peroxide / 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Benzoyl Peroxide / Tretinoin is used
A general measure of how commonly Benzoyl Peroxide / 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 Benzoyl Peroxide / 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.
How commonly is Benzoyl Peroxide / Tretinoin prescribed? Of the 1,596 medications we measure, Benzoyl Peroxide / Tretinoin ranks #1,450 by Medicaid prescriptions — more than 9% of them.
Utilization by Benzoyl Peroxide / 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.
benzoyl peroxide 30 MG/ML / tretinoin 1 MG/ML Topical Cream
Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2565807
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 Benzoyl Peroxide / 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 2 of 4 listed Benzoyl Peroxide / Tretinoin NDCs with Medicaid activity.
🔍 Compare Benzoyl Peroxide / Tretinoin products
A representative set of FDA-listed product records for Benzoyl Peroxide / 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 | ||||
| TRETINOIN 1 mg/g; BENZOYL PEROXIDE 30 mg/g | Topical | Galderma Laboratories, L.P. | NDA | View NDC → |
| 30; 1 mg/g; mg/g | Topical | Galderma Laboratories, L.P. × 2 listings | NDA | View NDC → |
| BENZOYL PEROXIDE 30 mg/g; TRETINOIN 1 mg/g | Topical | Mayne Pharma Commercial LLC | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Benzoyl Peroxide / Tretinoin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Benzoyl Peroxide / Tretinoin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Benzoyl Peroxide / Tretinoin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Benzoyl Peroxide / Tretinoin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 2565804 1 dose form · 1 strength
-
Dose form (SCDF) Topical Cream RxCUI 2565806In current FDA listingsClinical drug / strength (SCD) benzoyl peroxide 30 MG/ML / tretinoin 1 MG/MLRxCUI 2565807
Look up RxCUI 2565804 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.
📦 Supply & shortage status
Whether Benzoyl Peroxide / Tretinoin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Benzoyl Peroxide / Tretinoin belongs to the Retinoid class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 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. Galderma Laboratories, L.P. 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.