Label: XERBEX ECZEMA CREAM- colloidal oatmeal cream

  • 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 April 2, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Colloidal Oatmeal 1%   Skin Protectant

  • Uses

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

    • rashes
    • eczema
    • poison ivy, oak, or sumac
    • insect bites
  • Warnings

    For external use only

    Do not use

    • if allergic to any ingredients of this product

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive irritation of the skin develops
    • side effects occur. You may report side effects to FDA at 1–800–FDA–1088.

    Keep out of reach of children to avoid accidental poisoning .

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply as needed
  • Other information

    • store at room temperature, 20 to 25 oC(68 to 77 oF)
  • Inactive ingredients

    Arlacel 165, Cannabidiol (CBD), Carbomer, Ceteareth-20, Cetyl alcohol, Deionized water, Dimethicone, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Phenyl trimethicone, Stearic acid, Sorbitan stearate, Tromethamine, Xanthan Gum

  • Questions?

    Pacific Time 8:00am to 5:00pm

    1-626-822-8211

  • PRINCIPAL DISPLAY PANEL - 7.3 oz (206 g)

    NDC.No : 81021-011-01

    Xerbex Eczema Cream

    Skin Protectant

    Xerbex

    Xerbex Eczema Cream

  • INGREDIENTS AND APPEARANCE
    XERBEX ECZEMA CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81021-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81021-011-011 in 1 BOX04/01/2021
    1206 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2021
    Labeler - Xerbal USA LLC (117731081)
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