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

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 May 12, 2022

If you are a healthcare professional or from the pharmaceutical industry 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

    #1 Doctor Recommended
    Sensitive Skincare Brand
    Cetaphil®


    GENTLE CLEAR

    Mattifying Acne Moisturizer

    Salicylic Acid Acne Treatment

    Clinically proven technology to
    clear acne and help reduce the
    appearance of pores

    Bisabolol & Prebiotics soothe and
    strengthen skin barrier

    5 skin sensitivity signs

    3 FL OZ (89 mL)

    Distributed by: Galderma Laboratories, L.P., Fort Worth TX 76177 USA
    All trademarks are the property of their respective owners.
    cetaphil.com
    P56653-1


               

    P56653-1 Cetaphil Mattifying Acne Moisturizer 3oz Carton
  • 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 Product05/01/2021
    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(0299-4117)