Label: CETAPHIL ECZEMA SOOTHING MOISTURIZER- colloidal oatmeal lotion

  • NDC Code(s): 0299-4128-00, 0299-4128-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2024

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

  • Active ingredients......Purpose

    Colloidal Oatmeal 1%......Skin Protectant

  • PURPOSE

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:
    ●Eczema  ●Rashes

  • Warnings

    For external use only.

    When using this product ● Do not get into eyes.            

    Stop use and ask a Doctor if ● condition worsens ● symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed

  • Inactive Ingredients

    WATER, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PENTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, SORBITOL, BEHENYL ALCOHOL, GLYCERYL STEARATE, CETYL ALCOHOL, TOCOPHERYL ACETATE, ARGININE, NIACINAMIDE, GLYCERYL STEARATE CITRATE, SODIUM POLYACRYLATE, DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE, CAPRYLYL GLYCOL, CETEARETH-20, SODIUM PCA, PANTHENOL, CITRIC ACID, ALLANTOIN, DIMETHICONOL, OPHIOPOGON JAPONICUS ROOT EXTRACT, DISODIUM EDTA, MALTODEXTRIN, SODIUM HYALURONATE, CERAMIDE NP, PANTOLACTONE

  • Questions or comments?

    1-866-735-4137

    Distributed By:
    Galderma Laboratories, L.P.
    Dallas, TX 75201 USA

    All trademarks are the property of their respective owners

    Made in Canada

    cetaphil.com

  • PRINCIPLE DISPLAY PANEL - 10 FL OZ bottle

    NEW LOOK

    Cetaphil®

    ECZEMA

    RESTORADERM®

    Daily
    Soothing
    Moisturizer

    1% Colloidal Oatmeal
    Skin Protectant 
        

    Relieves and protects
    for fewer eczema
    symptoms over time

    Steroid Free

    National Eczema Association logo

    10 FL OZ (296 mL)

    P56332-2

    New front and back label
  • INGREDIENTS AND APPEARANCE
    CETAPHIL ECZEMA SOOTHING MOISTURIZER 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Sheanut Oil (UNII: O88E196QRF)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Sorbitol (UNII: 506T60A25R)  
    Docosanol (UNII: 9G1OE216XY)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Arginine (UNII: 94ZLA3W45F)  
    Niacinamide (UNII: 25X51I8RD4)  
    Glyceryl Stearate Citrate (UNII: WH8T92A065)  
    Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
    Disodium Ethylene Dicocamide Peg-15 Disulfate (UNII: QI9A6U005W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Panthenol (UNII: WV9CM0O67Z)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Allantoin (UNII: 344S277G0Z)  
    Dimethiconol (100000 Cst) (UNII: OSA9UP217S)  
    Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Ceramide Np (UNII: 4370DF050B)  
    Pantolactone, (R)- (UNII: J288D7O0JS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4128-00296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2022
    2NDC:0299-4128-0529 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/01/2022
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4128)