Label: CETAPHIL ECZEMA FLARE-UP CREAM- colloidal oatmeal cream

  • NDC Code(s): 0299-4139-00, 0299-4139-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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

  • Active ingredients......Purpose

    Colloidal Oatmeal 2%......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, ETHYLHEXYL PALMITATE, GLYCERIN, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIMETHICONE, PENTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM PCA, ARGININE, SODIUM POLYACRYLATE STARCH, CAPRYLYL GLYCOL, CITRIC ACID, SODIUM PHYTATE, CELLULOSE GUM, OPHIOPOGON JAPONICUS ROOT EXTRACT, XANTHAN GUM, TOCOPHERYL ACETATE, MALTODEXTRIN, CERAMIDE NP

  • Questions or comments?

    1-866-735-4137

    Distributed by:
    Galderma Laboratories, L.P.
    Dallas, TX 75201

    All trademarks are the property of their respective owners

    Made in Canada

    cetaphil.com

  • PRINCIPLE DISPLAY PANEL - 8 OZ tube

    Dermatologist Recommended
    For Sensitive Skincare 

    Cetaphil®

    ECZEMA

    RESTORADERM®

    Flare - Up
    Relief Cream

    1 Relieve, 2 Repair, 3 Protect        

    Relieves eczema symptoms after
    1 use and repairs skin's barrier

    Skin Protectant Colloidal Oatmeal

    Microbiome gentle Ad-Resyl®
    Steroid free

    National Eczema Association logo

    NET WT 8 OZ (227 g)

    P57252-0

    P57252-0 Eczema Flare up Cream tube
  • INGREDIENTS AND APPEARANCE
    CETAPHIL ECZEMA FLARE-UP CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4139
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sheanut Oil (UNII: O88E196QRF)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Arginine (UNII: 94ZLA3W45F)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Phytate Sodium (UNII: 88496G1ERL)  
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Ceramide Np (UNII: 4370DF050B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4139-00227 g in 1 TUBE; Type 0: Not a Combination Product02/01/2023
    2NDC:0299-4139-0510 g in 1 TUBE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/01/2023
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4139)