Label: ADAPALENE GEL 0.1% gel

  • NDC Code(s): 73715-003-01
  • Packager: MOHNARK PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 19, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Adapalene (retinoid) 0.1%

  • INACTIVE INGREDIENTS

    Inactive ingredients:

    Carbopol 980, edetate disodium, benzyl alcohol, Poloxamer 124, Propylene Glycol, Purified Water, Sodium Hydroxide

  • PURPOSE

    Acne Treatment

  • WARNINGS

    For external use only

  • USES

    For the treatment of acne

  • DO NOT USE

    • on damaged skin (cuts, abrasions, eczema, sunburn)
    • If you are allergic to adapalene or any of the ingredients in this product
  • WHEN USING THIS PRODUCT

    • limit sun exposure, including light from tanning beds and use sunscreen when going outdoors
    • do not wax to remove hair in areas where the product has been applied
    • during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you irritation that becomes severe
    • irritation (redness, itching, dryness, burning) is more likely to occur
    • in the first few weeks of use
    • if using more more than one topical acne medication at a time
    • but irritation usually lessens with continued use of this product
    • it may take up to 3 months of once daily use to see results
    • avoid product contact with eyes, lips and mouth. if contact occurs, immediately flush area with water
    • wash hands after use
  • STOP USE AND ASK A DOCTOR IF

    • you become pregnant, or are planning to become pregnant, while using this product
    • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids and shortness of breath)
    • irritation becomes severe
    • you see no improvement after 3 months of once daily use
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • DIRECTIONS

    Adults and children 2 years and older:

    • use once daily
    • clean the skin gently and pat dry before applying the product
    • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face
    • do not use more than one time a day. Applying more than directed will not provide faster results or better results, but may worsen skin irritation.

    Children under 12 years of age ask a doctor

  • OTHER INFORMATION

    • Store at USP controlled room temperature 20 - 25 0 C (68 - 77 0F)
    • protect from freezing
  • INDICATIONS AND USAGE

    Adapalene is a topical retinoid used for treating acne vulgaris

  • DOSAGE AND ADMINISTRATION

    Apply a thin film of Adapalene Gel, 0.1% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.

    For topical use only. Not for ophthalmic, oral or intravaginal use.

  • PRINCIPAL DISPLAY PANEL

    Carton Label - NDC 73715-003-01

    Adapalene Gel, 0.1%

    For external use only

    Once daily Topical Acne Treatment

    Net Wt 1 oz (30 grams)

    Adapalene carton

  • INGREDIENTS AND APPEARANCE
    ADAPALENE GEL 0.1% 
    adapalene gel 0.1% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73715-003-0130 g in 1 TUBE; Type 0: Not a Combination Product09/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/30/2024
    Labeler - MOHNARK PHARMACEUTICALS INC (117013830)