AV3630100 AVALON ORGANICS ECZEMA RELIEF BODY- colloidal oatmeal cream 
The Hain Celestial Group, Inc.

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.

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Avalon Organics Eczema Therapy Cream

Active Ingredient

Colloidal Oatmeal - 1.5%

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

Skin Protectant

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. If swallowed get medical help or contact Poison Center immediately.

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

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

AV36301 Label

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)

Revised: 4/2021
Document Id: bfc790c0-64fd-4ccd-e053-2995a90a2ecc
Set id: 60b5b3b1-a1a3-e84a-e053-2a91aa0ad4fd
Version: 6
Effective Time: 20210412
 
The Hain Celestial Group, Inc.