AV3630200 Avalon Organics Eczema Relief Gentle Cleanser

AV3630200 AVALON ORGANICS ECZEMA RELIEF GENTLE CLEANSER- colloidal oatmeal lotion
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.

----------

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.

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

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

bottle label

AV3630200 AVALON ORGANICS ECZEMA RELIEF GENTLE CLEANSER
colloidal oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61995-1302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61995-1302-8	325 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/08/2017

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc. (014334364)

Name	Address	ID/FEI	Business Operations
Establishment
The Hain Celestial Group, Inc.		081512382	manufacture(61995-1302)