Label: OILY SK SPECIFIC SOLUTIONS- 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
  • INDICATIONS & USAGE

    INDICATIONS AND INSTRUCTIONS FOR USE:  When blemish appears, apply directly on the affected area.  Use twice a day until the disappearance of the blemish.

  • WARNINGS

    WARNINGS:  For external use only.   Avoid contact with the eyes and mucous membranes.  Discontinue use if signs of irritation or rash appear.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:

    Salicylic Acid - .40% - Purpose: acne treatment

  • INACTIVE INGREDIENT

    COSMETIC INGREDIENTS:  WATER, ALCOHOL DENAT., GLYCERIN, HYDROXYETHYL ETHYLCELLULOSE, CAPRYLOYL GLYCINE, MALIC ACID, SODIUM SALICYLATE, CHLORHEXIDINE DIGLUCONATE, HYDROLYZED SWEET ALMOND PROTEIN, PLANTAGO LANCEOLATA LEAF EXTRACT, ZINC PCA, BERBERIS AQUIFOLIUM EXTRACT, BUTYLENE GLYCOL, SODIUM HYDROXIDE.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    INSTRUCTIONS FOR USE:  Squeeze a small amount onto the affected area twice a day until the blemish is gone.

  • PRINCIPAL DISPLAY PANEL

    Oily SK Specific Solution Carton

  • INGREDIENTS AND APPEARANCE
    OILY SK SPECIFIC SOLUTIONS 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.06 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    ALMOND (UNII: 3Z252A2K9G)  
    PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    MAHONIA AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75870-007-021 in 1 CARTON
    1NDC:75870-007-0115 mL in 1 TUBE
    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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