AV3630000 AVALON ORGANICS ECZEMA RELIEF INTENSIVE- 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.

----------

AV3630000 Avalon Organics Eczema Relief Intensive

Active Ingredient

Colloidal Oatmeal - 1.5%

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

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)

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

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

AV36300 Label

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)

Revised: 4/2021
Document Id: bfc79738-95c4-b1c2-e053-2a95a90ad7d9
Set id: 60b6eaa6-afab-24a7-e053-2991aa0a3862
Version: 6
Effective Time: 20210412
 
The Hain Celestial Group, Inc.