Label: OKEEFFES ECZEMA RELIEF HAND CREAM- colloidal oatmeal cream

  • NDC Code(s): 71564-003-02
  • Packager: The Gorilla Glue Company/O'Keeffe's Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2023

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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

    ©2020 Distributed by:

    O'Keeffe's Company

    Cincinnati, OH 45241

    Made in USA with Domestic and Imported Materials

  • PRINCIPAL DISPLAY PANEL

    NEW

    O'KEEFFE'S®

    CLINICAL | HAND

    ECZEMA RELIEF

    Hand Cream

    for extremely dry, itchy, irritated hands

    48 HOUR ITCH RELIEF IN ONE USE

    Colloidal Oatmeal Skin Protectant

    Dermatologist Tested

    Steroid & Fragrance Free

    GUARANTEED RELIEF

    Net Wt. 2 oz. (57 g)

    Eczema Relief 2oz Hand

  • INGREDIENTS AND APPEARANCE
    OKEEFFES ECZEMA RELIEF  HAND CREAM
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71564-003
    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
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-4 (UNII: 6HQ855798J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LAURETH-12 (UNII: OAH19558U1)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71564-003-0257 g in 1 TUBE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2020
    Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)
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