PROACTIV MD ADAPALENE ACNE TREATMENT- adapalene gel

Proactiv MD Adapalene by

Drug Labeling and Warnings

Proactiv MD Adapalene by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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

    • TAMPER EVIDENTl DONOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR VISIBLE.
    • store at 20° to 25°C (68°- 77°F) (see USP Controlled Room Temperature).
    • protect from freezing
  • Inactive ingredients

    carbomer, disodium EDTA, phenoxyethanol, poloxamer 182, propylene glycol, sodium hydrixide, water

  • SPL UNCLASSIFIED SECTION

    Distributed by Alchemee LLC,
    Hawthorne, NY 10532

    Made in Canada of Foreign

    and Domestic Components

  • Questions?

    1-800-950-4695

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Box

    proactivMD ®

    ADAPALENE GEL 0.1%
    ACNE TREATMENT

    PARABEN-FREE

    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 1.6 OZ (45 g)

    image 1

  • INGREDIENTS AND APPEARANCE
    PROACTIV MD ADAPALENE  ACNE TREATMENT
    adapalene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-958
    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)  
    POLOXAMER 182 (UNII: JX0HIX6OAG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 11410-958-451 in 1 BOX11/16/2023
    145 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC: 11410-958-151 in 1 BOX11/16/2023
    215 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21594011/16/2023
    Labeler - Alchemee, LLC (080216357)
    Registrant - Alchemee, LLC (080216357)
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