Label: ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 28, 2016

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 0.5%

    Purpose

    Acne Treatment

  • Uses

    for the treatment and prevention of acne pimples

  • Warnings

    for external use only.

    do not use

    if you have sensitive skin or are sensitive to Salicylic Acid.

    When using this product

    avoid contact with eyes, lips and mouth.

    • if using with other topical acne medications, at the same time or immediately following use of this product, increased dryness of the skin may occur. If this occurs, only one medication should be used unless otherwise directed by a doctor. Skin irritation may occur characterized by redness, burning, itching, peeling or possible swelling. Mild irriation may be reduced by using this product less frequently or lower concentration. Stop  use and ask a doctor if skin irritation becomes severe.

    KEEP OUT OF REACH OF CHILDREN.

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

  • Directions

    Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times day. Use to prevent new pimples from forming.

  • Other information

    • store at 15 - 30 C (59 - 86 F)
    • close cap tightly after use
    • do not use if seal on tube is punctured or missing
    • keep away from heat
  • Inactive ingredients

    DMDM HYDANTOIN, GLYCERIN, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL, WATER

  • Product Label

    ACNE TREATMENT

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-010-281 in 1 CARTON03/27/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/27/2015
    Labeler - McCure Health Solutions Inc. (053034873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Dedi Medical Device Co., Ltd..544458936manufacture(52486-010)
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