Label: CETAPHIL ECZEMA ITCH RELIEF GEL- colloidal oatmeal gel

  • NDC Code(s): 0299-4129-00, 0299-4129-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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

  • Active ingredients......Purpose

    Colloidal Oatmeal 0.5%......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

    ARGININE, BUTYLENE GLYCOL, C13-15 ALKANE, CARBOMER, CERAMIDE NP, ETHYLHEXYLGLYCERIN, GLYCERIN, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, LAURYL LACTATE, MALTODEXTRIN, OPHIOPOGON JAPONICUS ROOT EXTRACT, PENTYLENE GLYCOL, PHENOXYETHANOL, PROPANEDIOL, SODIUM GLUCONATE, SODIUM HYDROXIDE, SODIUM PCA, TOCOPHEROL (VITAMIN E), WATER, XANTHAN GUM

  • 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

    cetaphil.com

  • PRINCIPLE DISPLAY PANEL - 2 OZ carton

    Dermatologist Recommended
    For Sensitive Skin

    Cetaphil®

    ECZEMA

    RESTORADERM®

    Itch Relief Gel

    1 Relieve, 2 Repair, 3 Protect        

    Instantly soothes skin and relieves
    itch for up to 12 hours

    Skin Protectant Colloidal Oatmeal

    Microbiome gentle Ad-Resyl®
    Steroid free

    National Eczema Association logo

    2 FL OZ (59 mL)

    P56603-1

    (084009) P56603-1 Eczema Itch Relief Gel 2oz Carton
  • INGREDIENTS AND APPEARANCE
    CETAPHIL ECZEMA ITCH RELIEF GEL 
    colloidal oatmeal gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oatmeal (UNII: 8PI54V663Y) (Oatmeal - UNII:8PI54V663Y) Oatmeal0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Arginine (UNII: 94ZLA3W45F)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    C13-15 Alkane (UNII: 114P5I43UJ)  
    Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)  
    Ceramide Np (UNII: 4370DF050B)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
    Lauryl Lactate (UNII: G5SU0BFK7O)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Gluconate (UNII: R6Q3791S76)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Tocopherol (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4129-001 in 1 CARTON05/01/2022
    159 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:0299-4129-0510 mL in 1 TUBE; 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
    Fruit of The Earth, Inc.080086802manufacture(0299-4129)