Label: PROACTIV MD ADAPALENE ACNE TREATMENT- adapalene gel

  • NDC Code(s): 11410-956-17, 11410-956-38, 11410-956-44
  • Packager: The Proactiv Company, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated August 10, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Adapalene 0.1% (retinoid)1


    1
    read consumer information leaflet
  • Purpose

    Acne treatment

  • Use

    • For the treatment of acne
  • Warnings

    For external use only

    Do not use

    • on damaged skin (cuts, abrasions, eczema, sunburn)
    • if you are allergic to adapalene or any of the ingredients in this product.

    If pregnant or breast-feeding, ask a doctor before use.

    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 get irritation that becomes severe
    • irritation (redness, itching, dryness, burning) is more likely to occur:
      • in the first few weeks of use
      • if using 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 the 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 the 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 12 years of age 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 or better results, but may worsen skin irritation.

    Children under 12 years of age: ask a doctor

  • Other information

    • store at room temperature 68°- 77°F
    • protect from freezing
  • Inactive ingredients

    carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.

  • Questions?

    1-866-735-4137

  • SPL UNCLASSIFIED SECTION

    Distributed by The Proactiv Company LLC
    100 N Sepulveda Blvd., El Segundo, CA 90245

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Box

    proactiv MD®

    ADAPALENE GEL 0.1%
    ACNE TREATMENT

    First FDA-Approved
    Over-the-Counter
    Topical Retinoid* for
    Acne Treatment

    Previously Available
    Only By Prescription

    Dermatologist
    Developed and Tested

    *Read carton and enclosed consumer
    information leaflet before using
    this product. Keep this carton and
    consumer information leaflet.
    They contain important information.

    NET WT 0.5 OZ (15 g)

    PRINCIPAL DISPLAY PANEL - 15 g Tube Box
  • INGREDIENTS AND APPEARANCE
    PROACTIV MD ADAPALENE   ACNE TREATMENT
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-956
    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 HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 182 (UNII: JX0HIX6OAG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-956-441 in 1 BOX03/27/2017
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11410-956-171 in 1 BOX03/27/2017
    245 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:11410-956-381 in 1 BLISTER PACK08/09/2017
    32 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA AUTHORIZED GENERICNDA02038003/27/2017
    Labeler - The Proactiv Company, LLC (080216357)