Label: CETAPHIL BABY ECZEMA SOOTHING- colloidal oatmeal lotion

  • NDC Code(s): 0299-4140-05, 0299-4140-10
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 22, 2023

If you are a healthcare professional or from the pharmaceutical industry 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

    Allantoin, Arginine, Behenyl Alcohol, Butyrospermum Parkii, (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NP, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cyclopentasiloxane, Dimethiconol, Disodium EDTA, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Helianthus Annuus  (Sunflower) Seed Oil, Niacinamide, Panthenol, Pentylene Glycol, Sodium Hyaluronate, Sodium PCA, Sodium Polyacrylate, Sorbitol, Tocopheryl Acetate, Water

  • 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

    Made in Canada

    Cetaphil.com

  • PRINCIPLE DISPLAY PANEL - 10 oz bottle

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®

    baby

    Eczema
    Soothing Lotion

    1% Colloidal Oatmeal -

    Skin Protectant

    Baby's Sensitive skin

    Soothes dry, itchy, irritated skin
    Safe for babies > 3 months
    Steroid free

    NATIONAL
    ECZEMA
    ASSOCIATION LOGO

    10 FL OZ (296 ml)

    P55457-1

    (052169)P55457-1-Cetaphil BabyEczemaSoothingLotion10ozFL
  • INGREDIENTS AND APPEARANCE
    CETAPHIL BABY ECZEMA SOOTHING 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4140
    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
    Allantoin (UNII: 344S277G0Z)  
    Arginine (UNII: 94ZLA3W45F)  
    Docosanol (UNII: 9G1OE216XY)  
    Shea Butter (UNII: K49155WL9Y)  
    Medium-chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ceramide 3 (UNII: 4370DF050B)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethiconol (100000 Cst) (UNII: OSA9UP217S)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Disodium Ethylene Dicocamide Peg-15 Disulfate (UNII: QI9A6U005W)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Glyceryl Stearate Citrate (UNII: WH8T92A065)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Niacinamide (UNII: 25X51I8RD4)  
    Panthenol (UNII: WV9CM0O67Z)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sodium Polyacrylate (2500000 Mw) (UNII: 05I15JNI2J)  
    Sorbitol (UNII: 506T60A25R)  
    .alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4140-05147 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2018
    2NDC:0299-4140-10296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/01/2018
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4140)