Label: BHA CLEANSER 2%- salicylic acid lotion

  • NDC Code(s): 61328-403-01, 61328-403-15, 61328-403-55
  • Packager: Skinfix, Inc.
  • 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 February 3, 2022

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  • Active Ingredient

    SALICYLIC ACID 2%

  • Purpose

    ACNE TREATMENT

  • USES

    HELPS CLEAR ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

  • 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.
  • 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

  • Directions

    DISPENSE A PEA-SIZED AMOUNT ONTO DAMP PALMS AND WORK INTO A LATHER. MASSAGE OVER FACE AND NECK IN AN OUTWARD, CIRCULAR MOTIONS, CONCENTRATING ON OILY AND BREAKOUT-PRONE AREAS. RINSE THOROUGHLY WITH WARM WATER.

    ALLERGY ALERT  DO NOT USE THIS PRODUCT IF YOU HAVE A KNOWN ALLERGY TO SALICYLIC ACID.

  • Inactive Ingredients

    WATER (EAU), COCAMIDOPROPYL HYDROXYSULTAINE, STEARYL ALCOHOL, PROPANEDIOL, DISODIUM COCOYL GLUTAMATE, GLYCOLIC ACID, BENTONITE, NIACINAMIDE, SODIUM HYDROXIDE, AZELAIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHEROL, GLYCERIN, ETHYLHEXYLGLYCERIN, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, SODIUM COCOYL GLUTAMATE, XANTHAN GUM, SODIUM CHLORIDE, CITRIC ACID, POTASSIUM SORBATE, PHENOXYETHANOL, SODIUM BENZOATE

  • QUESTIONS?

    1.866.927.2783

  • PRINCIPAL DISPLAY PANEL

    61328-403-5561328-403-55

  • INGREDIENTS AND APPEARANCE
    BHA CLEANSER  2%
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-403
    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)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    BENTONITE (UNII: A3N5ZCN45C)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-403-551 in 1 BOX02/04/2022
    1NDC:61328-403-15148 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:61328-403-0130 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/04/2022
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGAN INDUSTRIES INC255106239manufacture(61328-403)
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