Label: AV3630200 AVALON ORGANICS ECZEMA RELIEF GENTLE CLEANSER- colloidal oatmeal lotion

  • 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 February 5, 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

    Water, Aloe Barbadensis Leaf Juice(1), Disodium Cocoyl Glutamate, Glyceryl Laurate, Glycerin, Glyceryl Stearate SE, Stearyl Alcohol, Cocos Nucifera (Coconut) Oil (1), Sodium Laurylglucosides Hydroxypropylsulfonate, Xanthan Gum, Linum Usatatissimum (Linseed) Seed Oil (1), Gluconolactone, Calcium Gluconate, Citric Acid, Sodium Chloride, Sodium Benzoate.

    (1) Certified Organicf Ingredient

  • INDICATIONS & USAGE

    Gentle cleanses skin and helps relieve minor skin irritation and iching due to eczema, rashes, dry skin.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    AV3630200 AVALON ORGANICS ECZEMA RELIEF GENTLE CLEANSER 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1302
    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
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1302-8325 g in 1 BOTTLE, PLASTIC; 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. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-1302)
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