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
  • 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 April 27, 2022

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.

    Fort Worth, TX 76177
    USA

    All trademarks are the property of their respective owners

    cetaphil.com.
    P56577-0


  • Principle Display Panel - 1 FL OZ Carton

    084012 P56577-0 GC Treatment Serum 1oz Carton2

    NEW

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®                 

    GENTLE CLEAR

    Triple-Action
    Acne Serum
    Salicylic Acid Acne Treatment



    Treats and prevents acne while
    reducing the appearance of
    post-acne marks

    With PHA, BHA
    Prebiotic and Succinic Acid

    5 skin sensitivity signs

    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 finalpart333D05/01/2022
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of The Earth, Inc.080086802manufacture(0299-4135)