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Altreno FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 29, 2018.

FDA Approved: Yes (First approved August 23, 2018)
Brand name: Altreno
Generic name: tretinoin
Dosage form: Lotion
Company: Ortho Dermatologics
Treatment for: Acne

Altreno (tretinoin) is a topical retinoid for the treatment of acne.

Important information: Altreno is for use on skin only. Do not use Altreno in your eyes, mouth, the corners of your nose, or vagina.

What is Altreno?

Altreno is a prescription medicine used on the skin (topical) to treat people with acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples.
It is not known if Altreno is safe and effective in children under 9 years of age.

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

  • are allergic to fish. Altreno contains fish proteins. Tell your healthcare provider if you get hives or itching while using Altreno.
  • have eczema or any other skin problems.
  • have a sunburn.
  • are pregnant or plan to become pregnant. It is not known if Altreno will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Altreno passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Altreno?

  • Use Altreno exactly as your healthcare provider tells you to use it.
  • Apply a thin layer of Altreno to cover the affected areas one time each day.

What should I avoid while using Altreno?

  • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with Altreno.
  • Minimize exposure to sunlight.
  • If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with a SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.

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

  • Skin irritation. Altreno may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you apply Altreno, or completely stop treatment with Altreno. Avoid applying Altreno to skin that is affected by eczema or sunburned skin.

These are not all the possible side effects of Altreno. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Altreno?

  • Store Altreno at room temperature between 68 to 77°F (20 to 25°C).
  • Do not freeze.

Keep all medicines out of the reach of children and pets.

What are the ingredients in Altreno?

Active ingredient: tretinoin
Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.

Development timeline for Altreno

Aug 24, 2018Approval Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne
Jan 12, 2018Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-121 Acne Treatment In Lotion Form

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.