Label: ACNE SPOT TREATMENT 2% BHA- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

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 24, 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

    APPLY DIRECTLY ONYO BLEMISH OR AFFECTED AREA AFTER CLEANSING 1-2X DAILY.

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

  • Inactive Ingredients

    WATER (EAU), KAOLIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, AZELAIC ACID, PROPANEDIOL, STEARYL ALCOHOL, POLYGLYCERYL-2 STEARATE, NIACINAMIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCERIN, BENTONITE, TOCOPHEROL, POLYDEXTROSE, DEXTRIN, AMYLOPECTIN, GLYCERYL STEARATE, ZINC PCA, STEARYL GLYCYRRHETINATE, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CITRIC ACID, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM BENZOATE

  • QUESTIONS?

    1.866.927.2783

  • PRINCIPAL DISPLAY PANEL

    0-UC_Acne Spot Treatment_0.5oz0-UC_Acne Spot Treatment_0.5oz

  • INGREDIENTS AND APPEARANCE
    ACNE SPOT TREATMENT  2% BHA
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-404
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    KAOLIN (UNII: 24H4NWX5CO)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENTONITE (UNII: A3N5ZCN45C)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-404-0515 mL in 1 TUBE; Type 0: Not a Combination Product03/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/16/2021
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGAN INDUSTRIES INC255106239manufacture(61328-404)
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