Label: ISOMERS CLEAR SKIN ACNE TREATMENT GEL- salicylic acid gel

  • 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 February 17, 2010

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  • ACTIVE INGREDIENT

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    ACTIVE INGREDIENT

    SALICYLIC ACID         2%

  • PURPOSE

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    PURPOSE

    ACNE TREATMENT

  • ASK DOCTOR

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    STOP USE AND ASK DOCTOR

    IF IRRITATION BECOMES SEVERE

  • KEEP OUT OF REACH OF CHILDREN

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    KEEP OUT OF REACH OF CHILDREN

  • WARNINGS

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    WARNING:

    • FOR EXTERNAL USE ONLY
    • KEEP AWAY FROM EYES
    • Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin, if this occurs only one medication should be used.
    • In case of accidental ingestion seek professional assistance or contact a poison control center immediately.
  • INACTIVE INGREDIENT

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    INACTIVE INGREDIENTS:

    Purified water, Propylene Glycol, Optunia Ficus Indica Stem Extract, Boerhavia Diffusa root Extract, Thermus Thermophilus Ferment, Glycerin, Pentylene Glycol, Zinc PCA,, Hydroxyethyl Cellulose, Phenoxyethanol, Decylene Glycol, Sodium Stearoyl Lactylate, Sodium Hydroxide.

  • PRINCIPAL DISPLAY PANEL

    CSATG240.jpgimage of product label

  • INGREDIENTS AND APPEARANCE
    ISOMERS CLEAR SKIN ACNE TREATMENT GEL 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64990-601-03240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/28/2009
    Labeler - Isomers Laboratories Inc (253306799)
    Registrant - Isomers Laboratories Inc (253306799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Isomers Laboratories Inc253306799manufacture
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