Label: CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER- salicylic acid lotion

  • NDC Code(s): 0299-4117-00, 0299-4117-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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

  • Active ingredient

    Salicylic Acid 0.5%

  • 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 becomes severe.

  • 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, Butylene Glycol, Cetearyl Alcohol, Dimethicone, Sodium Polyacrylate, Glycerin, Ceteareth-20, Polysorbate 60, Hydrogenated Polydecene, Ethylhexyl Palmitate, Aluminum Starch Octenylsuccinate, PPG-2 Myristyl Ether Propionate, Phenoxyethanol, Alpha-Glucan Oligosaccharide, Squalane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Zinc Gluconate, C12-15 Alkyl Lactate, Morus Alba Root Extract, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Safflower Oil/Palm Oil Aminopropanediol Esters, PPG-5-Laureth-5, Sodium Hydroxide, Kojic Acid, Hydroxypropyl Cyclodextrin, Sophora Angustifolia Root Extract, Disodium EDTA, Polyquaternium-11, Arctostaphylos Uva-Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Scutellaria Baicalensis Root Extract, Sodium Hyaluronate, Allantoin

  • Questions or comments?

    1-866-735-4137

    Distributed By:
    Galderma Laboratories, L.P.
    Fort Worth, TX 76177

    All trademarks are the property of their respective owners
    cetaphil.com

  • PRINCIPLE DISPLAY PANEL - 3 FL OZ Carton

    Cetaphil®


    ACNE
    GENTLE CLEAR

    Mattifying
    Acne
    Moisturizer

    0.5% Salicylic Acid Acne Treatment

    Oil Absorbing moisturizer
    provides a matte finish while
    clearing breakouts

    Salicylic Acid,
    Prebiotic

    Dermatologist Recommended
    Sensitive Skin 

    3 FL OZ (89 mL)

    Distributed by: Galderma Laboratories, L.P., Dallas TX 75201 USA
    All trademarks are the property of their respective owners.
    cetaphil.com
    Made in Canada
    P56653-3


               

    P56653-3
  • INGREDIENTS AND APPEARANCE
    CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4117
    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)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Hydrogenated Polydecene (550 Mw) (UNII: U333RI6EB7)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Ppg-2 Myristyl Ether Propionate (UNII: 88R97D8U8A)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    .Alpha.-Glucan Oligosaccharide (UNII: S95658MI3W)  
    Squalane (UNII: GW89575KF9)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    C12-15 Alkyl Lactate (UNII: GC844VRD7E)  
    Morus Alba Root (UNII: CST1G9BZGD)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Levomenol (UNII: 24WE03BX2T)  
    Safflower Oil (UNII: 65UEH262IS)  
    Ppg-25-Laureth-25 (UNII: 2R54TS98QU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Kojic Acid (UNII: 6K23F1TT52)  
    Hydroxypropyl Betadex (UNII: 1I96OHX6EK)  
    Sophora Flavescens Root (UNII: IYR6K8KQ5K)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Polyquaternium-11 (1000000 Mw) (UNII: 0B44BS5IJS)  
    Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)  
    Glycyrrhiza Glabra (UNII: 2788Z9758H)  
    Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Allantoin (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4117-001 in 1 CARTON05/01/2021
    189 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0299-4117-055 mL in 1 TUBE; Type 0: Not a Combination Product05/01/202105/02/2025
    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(0299-4117)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4117)