Label: OKEEFFES ECZEMA RELIEF BODY CREAM- colloidal oatmeal cream

  • NDC Code(s): 71564-004-05, 71564-004-07, 71564-004-08
  • Packager: The Gorilla Glue Company/O'Keeffe's Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Colloidal oatmeal 2%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes
    • eczema
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product do not get into eyes

  • STOP USE

    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

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

  • DOSAGE & ADMINISTRATION

    Directions

    apply as needed

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octylsuccinate, Cetearyl Alcohol, Ceteareth-20, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, Panthenol, Allantoin, 1,2-Hexanediol, Caprylyl Glycol, Polyquaternium-10, Beeswax, Caesalpinia Spinosa Gum, Bisabolol, Disodium EDTA, Zingiber Officianale (Ginger) Root Extract, Glyceryl Stearate, PEG-100 Stearate, Laureth-4, Laureth-23, Laureth-12, Phenoxyethanol, Ethylhexyglycerin

  • SPL UNCLASSIFIED SECTION

    OKeeffesCompany.com

    Questions/Comments: 1-800-275-2718

    ©2021 Distributed by:

    O'Keeffe's Company

    Cincinnati, OH 45241

    Made in USA with Domestic and Imported Materials

  • PRINCIPAL DISPLAY PANEL

    O'KEEFFE'S®

    CLINICAL | BODY

    ECZEMA RELIEF

    BODY CREAM

    48 HOUR ITCH RELIEF IN ONE USE

    Colloidal Oatmeal Skin Protectant

    Dermatologist Tested

    Steroid & Fragrance Free

    GUARANTEED RELIEF

    for extremely dry, itchy, irritated skin

    Net Wt. 8 oz. (227 g)

    71564-004 ECZEMA RELIEF 01-2022

  • INGREDIENTS AND APPEARANCE
    OKEEFFES ECZEMA RELIEF  BODY CREAM
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71564-004
    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
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LAURETH-12 (UNII: OAH19558U1)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LAURETH-23 (UNII: N72LMW566G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINGER (UNII: C5529G5JPQ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-4 (UNII: 6HQ855798J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71564-004-08227 g in 1 TUBE; Type 0: Not a Combination Product07/01/2020
    2NDC:71564-004-077 g in 1 TUBE; Type 0: Not a Combination Product08/06/2020
    3NDC:71564-004-05142 g in 1 TUBE; Type 0: Not a Combination Product08/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/01/2020
    Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)
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