Label: BLACKHEAD CLEARING SCRUB- 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 March 24, 2022

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  • Active ingredient

    Salicylic acid (2%)

  • Purpose

    Acne medication 

  • Uses 

    • for the treatment of acne
    • clears blackheads
  • Warnings

    For external use only

  • When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
    • avoid contact with the eyes.  If contact occurs, flush thoroughly with water.
  • Keep out of reach of children

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

  • Directions

    moisten face with water.  Apply product with wet fingertips and massage over face.  Rinse well and pat dry.

  • Other information

    store at room temperature

  • Inactive ingredients

    water, cetyl alcohol, PPG-15 stearyl ether, synthetic wax, microcrystalline wax, steareth-21, polysobate 60, potassium cetyl phosphate, xanthan gum, fragrance, menthyl lactate, jojoba esters, ferric ferrocyanide

  • SPL UNCLASSIFIED SECTION

    We hope you are satisfied with this product.  If not, we will cheerfully refund your money.

    Distributed By:

    H-E-B San antonio, TX 78204

    Questions: 1-888-593-0593

    MADE IN THE US WITH US AND FOREIGN COMPONENTS

  • principal display panel

    HILL COUNTRY ESSENTIALS

    Blackhead Clearing Scrub

    Salicylic Acid Acne Medication

    Gently exfoliates to remove dirt & oil

    NET WT 5 OZ (141 g)

    image description

  • INGREDIENTS AND APPEARANCE
    BLACKHEAD CLEARING SCRUB 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID19.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    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)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    FERRIC FERROCYANIDE (UNII: TLE294X33A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-219-56141 g in 1 TUBE; Type 0: Not a Combination Product06/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/23/2009
    Labeler - H E B (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-219)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-219)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemrite623776502manufacture(37808-219)
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