Label: ACNE- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 August 30, 2016

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  • DESCRIPTION

    GLW PERSONAL CARE SOLUTIONS

    Deep Cleaning Astringent

    Sensitive Skin

    Salicylic Acid acne treatment

    Gentle yet effective cleanser that helps treat and prevent pimples.

    8 FL OZ (240 mL)

  • ACTIVE INGREDIENT

    Active Ingedient Purpose

    Salicylic Acid 0.5%...............................................................Acne treatment

  • PURPOSE

    Deep Cleaning acne treatment

  • INDICATIONS & USAGE

    For treatment of acne

  • WARNINGS

    For external use only.

    Flammable, keep away from open flame

    When using this product, avoid contact with eyes. If contact occurs, immediately flush with water.

    Using other topical acne medications at the same time or immediately following use of this product may increase dryness of irritation of the skin. If this occurs, only one medication should be used, unless directed by a doctor.c

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Topical sensitive skin cleaning solution

    0.5% Salicylic Acid

  • INSTRUCTIONS FOR USE

    • Cleanse the skin thoroughly before applying medication
    • Moisten a cotton ball or pad
    • Cover the entire affected area with a thin layer 1 to 3 times daily
    • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor..
    • If bothersome drying or peeling occurs, reduce application to once a day or every other day.
  • INACTIVE INGREDIENT

    water (aqua), alcohol, propylene glycol, glycerin, PEG-32, algae extract, DMDM hydantion, dimethicone propyl PG-betaine, sodium citrate, aloe barbadensis leaf exract, benzophenone-4, denatonium benzoate, fragrance, FD&C Blue No. 1.

  • PRINCIPAL DISPLAY PANEL

    Astringent

  • INGREDIENTS AND APPEARANCE
    ACNE 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.2 g  in 240 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-325-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/30/2016
    Labeler - Great Lakes Wholesale, Marketing and Sales Inc (361925498)
    Registrant - Illinois Industrial Tool, Inc (628032898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Liyuan Chemical Products Co., Ltd.530766098manufacture(64092-325)
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