Label: ACNE BODY WASH- salicylic acid soap

  • NDC Code(s): 82575-100-10, 82575-200-20
  • Packager: Curology
  • 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 December 5, 2022

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  • Active Ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Uses

    For the treatment of acne

  • Warnings

    • For external use only.

    • When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by doctor.

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Dampen skin and massage a thin layer onto the entire affected area, then rinse thoroughly.
    • Because drying of skin may occur, start with one daily application, then gradually increase to two or three times daily, if needed or directed by a doctor.
    • If excessive dryness or peeling occurs, reduce application to once a day or every other day.
  • Other Information

    Store at 20-25°C (68-77°F)

  • Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, Cocamidopropyl Dimethylamine, Polyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Hydroxypropyl Methylcellulose, Phenoxyethanol, Sodium Chloride, Zinc Pyrithione, Sodium Hydroxide, Polyquaternium-7, Ethylhexylglycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Sodium Benzoate

  • Principal Display Panel - 100 ml Bottle Label

    Curology

    Acne Body Wash

    Gentle foaming formula

    2% salicylic acid treatment

    DERMATOLOGIST

    FOUNDED DEVELOPED TESTED

    100 ml/3.4 fl oz

    Principal Display Panel - 100 ml Bottle Label
  • Principal Display Panel - 200 ml Bottle Label

    Curology

    Acne Body Wash

    Gentle foaming formula

    2% salicylic acid treatment

    DERMATOLOGIST

    FOUNDED DEVELOPED TESTED

    200 ml/6.8 fl oz

    Principal Display Panel - 200 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ACNE BODY WASH 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Cocamidopropyl Dimethylamine (UNII: L36BM7DG2T)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Polyglyceryl-4 Caprate (UNII: 3N873UN885)  
    Polyglyceryl-6 Caprylate (UNII: DGV8R54VG7)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Pyrithione Zinc (UNII: R953O2RHZ5)  
    Polyquaternium-7 (70/30 Acrylamide/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Edetic Acid (UNII: 9G34HU7RV0)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Formaldehyde/Sodium Naphthalenesulfonate Copolymer (3000 MW) (UNII: 90D834OZUI)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Magnesium Nitrate (UNII: 77CBG3UN78)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82575-100-10100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/05/2022
    ACNE BODY WASH 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Cocamidopropyl Dimethylamine (UNII: L36BM7DG2T)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Polyglyceryl-4 Caprate (UNII: 3N873UN885)  
    Polyglyceryl-6 Caprylate (UNII: DGV8R54VG7)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Pyrithione Zinc (UNII: R953O2RHZ5)  
    Polyquaternium-7 (70/30 Acrylamide/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Edetic Acid (UNII: 9G34HU7RV0)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Formaldehyde/Sodium Naphthalenesulfonate Copolymer (3000 MW) (UNII: 90D834OZUI)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Magnesium Nitrate (UNII: 77CBG3UN78)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82575-200-20200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/05/2022
    Labeler - Curology (104103284)
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