Label: BLACKHEAD CLEARING SCRUB- salicyclic acid rinse

  • 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 October 23, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient - Salicylic Acid 2%

  • PURPOSE

    Purpose - Acne Treatment

  • INDICATIONS & USAGE

    Uses

    • for the treatment of acne
    • clean blackheads
  • WARNINGS

    Warning

    For external use only

  • WHEN USING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet face
    • gently massage all over face for 20-30 seconds
    • rinse thoroughly and pat dry
    • recommended for daily use
  • INACTIVE INGREDIENT

    Water, Cetyl Alcohol, PPG-15 Stearyl Ether, Glycolic Acid, Microcrystalline wax, Steareth - 21, Polysorbate 60, potassium cetyl phosphate, xanthan gum, fragrance, menthyl lactate, jojoba esters

  • PRINCIPAL DISPLAY PANEL

    Blackhead Clearing Scrub

  • INGREDIENTS AND APPEARANCE
    BLACKHEAD CLEARING SCRUB 
    salicyclic acid rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-204-05141 mg in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/01/2016
    Labeler - Brands International Corp (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corp243748238manufacture(50157-204)
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