Label: CETAPHIL GENTLE CLEAR CLARIFYING ACNE CLEANSER- salicylic acid cream

  • NDC Code(s): 0299-4119-00, 0299-4119-05
  • Packager: Galderma Laboratories, L.P.
  • 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 23, 2022

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  • 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 are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.
    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation become 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, avoiding the eye area. Rinse thoroughly and pat dry. Designed for twice daily use. Can be used less frequently if dryness occurs.

  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Sodium Methyl Cocoyl Taurate, Sodium Chloride, Cetyl Alcohol, Stearyl Alcohol, PEG-120 Methyl Glucose Dioleate, Phenoxyethanol, Sodium Hydroxide, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Butylene Glycol, Camellia Sinensis Leaf Extract

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 4.2 FL OZ tube


    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil          

    Gentle Clear

    Clarifying Acne
    Cream Cleanser

    Salicylic Acid
    Acne Treatment

    Deep cleans without
    over-drying

    Immediately starts
    working to clear acne
    and to help prevent
    future breakouts

    White Tea &
    Aloe Soothe Skin

    5 skin sensitivity signs
    4. 2 FL OZ (124 mL)

    Carton artwork P56561-0
  • INGREDIENTS AND APPEARANCE
    CETAPHIL GENTLE CLEAR CLARIFYING ACNE CLEANSER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4119
    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)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)  
    Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4119-00124 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    2NDC:0299-4119-055 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/01/2021
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Essence, LLC dba Voyant Beauty032565959manufacture(0299-4119)
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