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Twyneo: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
30 mg/g, 1 mg/g
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Twyneo

What is TWYNEO?

TWYNEO is a prescription medicine used on the skin (topical) to treat acne vulgaris in adults and children 9 years of age and older.

It is not known if TWYNEO is safe and effective in children below 9 years of age.

Do not use TWYNEO if you have had an allergic reaction to benzoyl peroxide or any of the ingredients in TWYNEO. See the end of this leaflet for a complete list of ingredients in TWYNEO.

Before using TWYNEO, tell your healthcare provider about all of your medical conditions, including if you:

  • have other skin problems, including eczema, cuts, or sunburn
  • have skin sensitivity to the sun
  • are pregnant or planning to become pregnant. It is not known if TWYNEO wi l harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if TWYNEO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with TWYNEO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use TWYNEO?

  • Use TWYNEO exactly as your healthcare provider tells you to use it.
  • Apply TWYNEO to the affected areas 1 time a day.
  • Apply TWYNEO on clean and dry skin.
  • TWYNEO come in a bottle with a pump. Press down on (depress) the pump to dispense a small amount of TWYNEO on your fingertip. Apply a thin layer of TWYNEO to the affected areas. Avoid contact with your eyes, lips, corners of your nose, and mouth.
  • Wash your hands right away after applying TWYNEO.

What should I avoid while using TWYNEO?

  • Avoid using TWYNEO on skin areas with cuts, abrasions, eczema, or sunburns.
  • Limit your time in sunlight. You should avoid using sunlamps, tanning beds, and ultraviolet light during treatment with TWYNEO. If you have to be in the sunlight or are sensitive to sunlight, use sunscreen and wear protective clothing or a wide- brimmed hat to cover the treated areas.
  • Avoid getting TWYNEO in your hair or on colored fabric. TWYNEO may bleach hair or colored fabric.

What are the possible side effects of TWYNEO? TWYNEO may cause serious side effects including:

  • Allergic reactions. Stop using TWYNEO and get medical help right away if you have any of the following symptoms during treatment with TWYNEO:

    • hives, rash or severe itching
    • swelling of your face, eyes, lips, tongue, or throat
    • trouble breathing or throat tightness
    • feeling faint, dizzy, or lightheaded

  • Skin irritation. TWYNEO may cause skin irritation such as redness, scaling, peeling, dryness, pain, stinging or burning. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you

    apply TWYNEO, or completely stop treatment of TWYNEO.

The most common side effects of TWYNEO include pain, dryness, peeling, redness, swe ling, itching, and irritation at the application site.

These are not all possible side effects of TWYNEO.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

How should I store TWYNEO?

  • Store TWYNEO at room temperature between 68°F to 77°F (20C° to 25°C).
  • Throw away (discard) TWYNEO 12 weeks after the date you receive it or 60 days after first opening, whichever is sooner.
  • Do not freeze.

Keep TWYNEO and all medicines out of reach of children.

General information about the safe and effective use of TWYNEO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TWYNEO for a condition for which it was not prescribed. Do not use TWYNEO for a condition for which it was not prescribed. Do not give TWYNEO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TWYNEO that is written for health professionals.

What are the ingredients in TWYNEO?

Active Ingredients: tretinoin and benzoyl peroxide

Inactive Ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer type C, cetrimonium chloride, cetyl alcohol, cyclomethicone, edetate disodium, glycerin, hydrochloric acid, imidurea, (S)-lactic acid, macrogol stearate, mono and di-glycerides, polyquaternium-7, purified water, silicon dioxide, sodium hydroxide, squalane, tetraethyl ortho silicate and white wax.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 214902 · View the label on DailyMed

Revision date stated in the text: February 2025

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Twyneo

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Retinoid
Active ingredients Benzoyl peroxide 30 mg/g, Tretinoin 1 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) MAYNE PHARMA
FDA approval NDA 214902New Drug Application (NDA) Approved July 26, 2021
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
30 mg/g, 1 mg/g – 30 g in 1 bottle, pump / 1 in 1 carton NDC 51862-771-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.