Label: AV3630000 AVALON ORGANICS ECZEMA RELIEF INTENSIVE- 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

    Instantly sootheand protect skin by smoothing over areas of intense irritation.

  • 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)

    Carthamus Tinctorius (Safflower) Seed Oil (1)

    Cocos Nucifera (Coconut) Oil (1)

    Glycerin

    Cetearyl Olivate

    Shea Butter Ethyl Esters

    Sorbitan Olivate

    Glyceryl Stearate SE

    Aqua (Purified Water)

    Butyrospermum Parkii (Shea) Butter (1)

    Linum Usitatissimum (Linseed) Seed Oil (1)

    C10-18 Triglycerides

    Gluconolactone

    Behenyl Alcohol

    Archidyl Alcohol

    Arginine

    Biosaccharide gum-1

    Calcium Gluconate

    Glyceryl Caprylate

    Sodium Anisate

    Sodium Levulinate

    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

    AV36300 Label

  • INGREDIENTS AND APPEARANCE
    AV3630000 AVALON ORGANICS ECZEMA RELIEF INTENSIVE 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1300
    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
    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)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1300-389 g in 1 TUBE; 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(61995-1300)
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