Label: TRETINOIN cream

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 11, 2025

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  • SPL UNCLASSIFIED SECTION
    For Topical Use Only - Prescribing Information
  • Description
    Tretinoin Cream USP, 0.025% is used for the topical treatment of acne vulgaris. Tretinoin cream contains tretinoin in 0.025% by weight, in a hydrophilic cream vehicle of butylated hydroxytoluene ...
  • Clinical Pharmacology
    Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo ...
  • Indications and Usage
    Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not ...
  • Contraindications
    Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
  • Warnings
    Keep out of reach of children. Keep tube tightly closed. Do not expose to heat. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from freezing.
  • Precautions
    General - If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during ...
  • Adverse Reactions
    The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of ...
  • Overdosage
    If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side ...
  • Dosage and Administration
    Tretinoin cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application may cause a transitory ...
  • How Supplied
    Tretinoin Cream USP, 0.025% is supplied as: ● 20 gram - 51672-1407-0 - ● 45 gram - 51672-1407-9 - Storage Conditions - Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room ...
  • SPL UNCLASSIFIED SECTION
    Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532 Issued: May 2021 5216018 29 Relabeled ...
  • PATIENT INSTRUCTIONS Tretinoin Cream USP, 0.025%
    Acne Treatment - For Topical Use Only IMPORTANT - Read Directions Carefully Before Using - THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE TREATMENT AS PRESCRIBED BY YOUR PHYSICIAN. THIS ...
  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
    NDC 68788-8857-2 - 45 g - Tretinoin Cream USP, 0.025% FOR TOPICAL USE ONLY. Rx only Keep this and all medications out of the reach of children. TARO - Relabeled By: Preferred ...
  • INGREDIENTS AND APPEARANCE
    Product Information