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

Drug Label Information

Updated November 20, 2023

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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.          
    Dallas, TX 75201 USA

    All trademarks are the property
    of their respective owners.

    cetaphil.com
    P56651-2

  • PRINCIPAL DISPLAY PANEL - 4.2 FL OZ tube


    NEW LOOK
    Cetaphil          

    Gentle Clear

    Clarifying
    Acne Cream
    Cleanser

    2% Salicylic Acid
          Acne Treatment

    Deep cleans and exfoliates
    to unclog pores preventing
    future breakouts

    Salicylic Acid, White Tea
    & Aloe

    Dermatologist Recommended
    Sensitive Skin logo

    4. 2 FL OZ (124 mL)

    P56651-2 tube
  • 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 DrugM00605/01/2021
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Essence, LLC dba Voyant Beauty032565959manufacture(0299-4119)
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