Label: CETAPHIL ACNE RELIEF BODY WASH- salicylic acid gel

  • NDC Code(s): 0299-4121-00
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 20, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Use

    For the management of acne

  • 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.

  • Stop use and ask a doctor if

    • irritation becomes severe.

  • Keep out of reach of children.

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

  • Directions

    Apply to dampened skin and gently massage. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application use.

  • Inactive Ingredients

    BENZYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, COCAMIDOPROPYL BETAINE, GLYCERIN, GLYCINE SOJA (SOYBEAN) OIL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROGENATED SOYBEAN OIL, HYDROXYPROPYL STARCH PHOSPHATE, LACTIC ACID, LAURIC ACID, PALMITIC ACID, PHENOXYETHANOL, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYDROXIDE, SODIUM LAUROYL GLYCINATE, SODIUM LAUROYL ISETHIONATE, STEARIC ACID, TETRASODIUM EDTA, WATER

  • SPL UNCLASSIFIED SECTION

    Distributed by: Galderma Laboratories, L.P.          
    Fort Worth, TX 76177 USA
    cetaphil.com

  • PRINCIPAL DISPLAY PANEL - 20 FL OZ bottle


    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®          

    ACNE RELIEF
    BODY WASH

    Acne-Prone Skin

    Maximum strength
    OTC formula
    to eliminate breakouts

    24 hour dryness relief

    Advanced Moisture Blend
    2% Salicylic Acid
    Acne Treatment

    5 skin sensitivity signs
    20 FL OZ (591 mL)
    P55982-1

    Cetaphil Acne Relief BodyWash Front Back Labels
  • INGREDIENTS AND APPEARANCE
    CETAPHIL ACNE RELIEF BODY WASH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4121
    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
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Shea Butter (UNII: K49155WL9Y)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Glycerin (UNII: PDC6A3C0OX)  
    Soybean Oil (UNII: 241ATL177A)  
    Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) (UNII: B16G315W7A)  
    Hydrogenated Soybean Oil (UNII: A2M91M918C)  
    Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
    Lauric Acid (UNII: 1160N9NU9U)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Lauroyl Glycinate (UNII: L54QIO80PN)  
    Sodium Lauroyl Isethionate (UNII: M590021Z02)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4121-00591 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/01/2022
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc080086802manufacture(0299-4121)