Label: BLACKHEAD CLEANING SCRUB- salicylic acid cream

  • 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 January 13, 2016

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  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid  2%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses  for the treatment of acne

  • WARNINGS

    Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

    Ask a doctor or pharmacist before using other topical

    acne medications at the same time or immediately

    following use of this product. May increase dryness or

    irritation of the skin. If this occurs, only one medication

    should be used unless directed by a doctor.

    When using this product apply to affected area only.

    Do not use on broken skin or apply to large areas of the

    body.

  • 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 20-30

    seconds, avoiding eye area    -Rinse thoroughly and pat dry

    -Recommended for daily use

  • STORAGE AND HANDLING

    Other information store at room

    temperature 68 - 86 F (20 - 30 C)

  • INACTIVE INGREDIENT

    Inactive ingredients  water, cetearyl alcohol,

    microcrystalline wax, paraffin, polysorbate 60, steareth-21,

    aloe barbadensis leaf juice, propylene glycol, jojoba esters,

    xanthan gum, menthyl lactate, ultramarines (blue)


  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    BLACKHEAD CLEANING SCRUB 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-031-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/11/2016
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-031)
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