Label: ADVANCED ACNE SPOT TREATMENT CVS- salicylic acid 2.00% lotion

  • 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 December 26, 2017

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  • Active ingredient                          Purpose

    Salicylic Acid – 2.00%                  Acne Medication

  • PURPOSE

  • Use

    For treatment of acne

  • WarningsFor external use only

    ​Flammable. Keep away from fire or flame.

    ​When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor.

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water

  • DOSAGE & ADMINISTRATION

    Directions ​• cleans the skin thoroughly before applying medication • cover the entire affected area with a thin layer one to three times a day • If bothersome dryness or peeling occurs, reduce application to once a day or every other day. • Recomended for daily use.

  • INACTIVE INGREDIENT

    Inactive ingredients :Water, Alcohol, Hamamelis Virginiana (Witch Hazel) Extract, Glycerin, C13-14 Isoparaffin, Laureth-7, Polyacrylamide
    C12-15 Alkyl Lactate, Cetyl Lactate, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Butylene Glycol, Dimethicone, Capryloyl Glycine, Ammonium Hydroxide, Portulaca Oleracea Extract, Benzalkonium Chloride, Propylene Glycol, Cocamidopropyl PG-Dimonium , hloride Phosphate, Cyclopentasiloxane, Phenoxyethanol, Dehydroxanthan Gum, Denatonium Benzoate, Fragrance, Hexylene Glycol, Polysorbate 20, PPG-2 Isoceteth-20 Acetate, Sarcosine, t-Butyl Alcohol, Tetrasodium EDTA

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ADVANCED ACNE SPOT TREATMENT  CVS
    salicylic acid 2.00% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-343
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    Glycerin (UNII: PDC6A3C0OX)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Laureth-7 (UNII: Z95S6G8201)  
    C12-15 Alkyl Lactate (UNII: GC844VRD7E)  
    Cetyl Lactate (UNII: A7EVH2RK4O)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    AMMONIA (UNII: 5138Q19F1X)  
    PURSLANE (UNII: M6S840WXG5)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Dehydroxanthan Gum (UNII: 63ZP7I1BQO)  
    Denatonium Benzoate (UNII: 4YK5Z54AT2)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    PPG-2 Isoceteth-20 Acetate (UNII: BI6C7YO419)  
    Sarcosine (UNII: Z711V88R5F)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-343-011 in 1 CARTON12/22/2014
    122 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/22/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(59779-343) , label(59779-343)
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