Label: AV3630100 AVALON ORGANICS ECZEMA RELIEF BODY- 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 12, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient

    Colloidal Oatmeal - 1.5%

  • DOSAGE & ADMINISTRATION

    Massage cleanser over damp face and body, rinse clean, pat dry. Following immediately with an Eczema Relief cream locks in moisture.

  • PURPOSE

    Skin Protectant

  • WARNINGS

    For external use only. Avoid contacts with eyes. Stop use and ask a doctor if symptoms last more than 7 days or condition worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact Poison Center immediately.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice(1), Glycerin, Water, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil (1), Glyceryl Stearate SE, Butyrospermum Parkii(Shea Butter(1), Cetearyl Olivate, Shea Butter Ethyl Esters, Sorbitan Olivate, Gluconolactone, , Linum Usatatissimum (Linseed) Seed Oil (1), Archidyl Alcohol, Arginine, Behenyl Alcohol, Calcium Gluconate, Stearyl Alcohol, Potassium Sorbate, Sodium Benzoate.

    (1) Certified Organic Ingredient

  • INDICATIONS & USAGE

    Helps protect and relieve skin irritation and itching due to: Eczema, Rashes, Dry skin.

  • PRINCIPAL DISPLAY PANEL

    AV36301 Label

  • INGREDIENTS AND APPEARANCE
    AV3630100 AVALON ORGANICS ECZEMA RELIEF BODY 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    ARGININE (UNII: 94ZLA3W45F)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1301-8296 g in 1 JAR; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/08/2017
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-1301)
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