Label: OILY SK CLEANSING- 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 June 21, 2011

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  • PURPOSE

    Purpose:  Acne Treatment

  • ACTIVE INGREDIENT

    Active Ingredient:

    Salicylic Acid 1%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

     Uses:  For the daily cleansing of acne and oily-prone skin. 

  • WARNINGS

    Warnings:

    • For external use only. 
    • Avoid contact with eyes and mucous membranes. 
    • Discontinue use if signs of irritation or rash appear.
  • DOSAGE & ADMINISTRATION

    Directions:   Apply Cleansing Gel to previously moistened skin with a gentle massage until a soft lather is produced.  Leave for 1-2 minutes and then rinse.

  • INACTIVE INGREDIENT


    COSMETIC INGREDIENTS:  WATER, DISODIUM COCOAMPHODIACETATE, PEG-7 CLYCERYL COCOATE, COCAMIDOPROPYL BETAINE, PEG-200 HYDROGENATED GLYCERYL PALMATE, SODIUM CHLORIDE, ZINC PCA, MENTHYL LACTATE, CHLORHEXIDINE DIGLUCONATE, ALLANTOIN, CITRUS MEDICA LIMONUM (LEMON) PEEL OIL, MENTHA PIPERITA (PEPPERMINT) OIL, POLYSORBATE 80, PHENOXYETHANOL, 2,4-DICHLOROBENZYL ALCOHOL, PROPYLENE GLYCOL, GLYCERIN.
  • PRINCIPAL DISPLAY PANEL

    Image of carton label

  • INGREDIENTS AND APPEARANCE
    OILY SK CLEANSING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.15 mL  in 115 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    MENTHYL LACTATE (UNII: 2BF9E65L7I)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LEMON OIL (UNII: I9GRO824LL)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75870-008-021 in 1 CARTON
    1NDC:75870-008-01115 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/15/2008
    Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE (467582193)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE 467582193manufacture
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