Label: CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM- salicylic acid solution

  • NDC Code(s): 0299-4135-00, 0299-4135-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Salicylic Acid 0.5% 

  • Purpose

    Acne treatment

  • Uses

    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 treatment at a time. ■ avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if
    ■ irritation becomes severe

  • 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

    Sensitivity Test for New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below. • clean the skin thoroughly before applying this product. • cover the entire affected area with a thin layer one to three times daily • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

  • Inactive Ingredients

    WATER, GLYCERIN, COCO-CAPRYLATE/CAPRATE, GLUCONOLACTONE, PROPANEDIOL, SODIUM HYDROXIDE, SUCCINIC ACID, PANTHENOL, NIACINAMIDE, LYSOLECITHIN, SCLEROTIUM GUM, ZINC GLUCONATE, PULLULAN, XANTHAN GUM, PANTOLACTONE, CITRIC ACID, SILICA

  • STORAGE AND HANDLING

  • Questions or comments?

    1-866-735-4137

  • QUESTIONS

    Distributed by:

    Galderma Laboratories, L.P.

    Dallas, TX 75201 USA

    All trademarks are the property of their respective owners.

    cetaphil.com.
    P56577-1


  • Principle Display Panel - 1 FL OZ Carton

    triple action serum carton

    NEW LOOK

    Cetaphil®                 

    ACNE
    GENTLE CLEAR

    Triple-Action
    Acne Serum

    0.5% Salicylic Acid Acne Treatment



    Hydrates, soothes and
    resurfaces to visibly improve
    breakouts in 3 days

    Salicylic Acid,
    Niacinamide
    & Prebiotic 

    Dermatologist Recommended
    Sensitive Skin

    1 FL OZ (30 mL)









  • INGREDIENTS AND APPEARANCE
    CETAPHIL GENTLE CLEAR TRIPLE-ACTION ACNE SERUM 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Succinic Acid (UNII: AB6MNQ6J6L)  
    Panthenol (UNII: WV9CM0O67Z)  
    Niacinamide (UNII: 25X51I8RD4)  
    Lysophosphatidylcholine, Soybean (UNII: CQD833204Z)  
    Betasizofiran (UNII: 2X51AD1X3T)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Pullulan (UNII: 8ZQ0AYU1TT)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Pantolactone, (R)- (UNII: J288D7O0JS)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4135-001 in 1 CARTON05/01/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0299-4135-055 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00605/01/2022
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc.080086802manufacture(0299-4135)