AV3630000 AVALON ORGANICS ECZEMA RELIEF INTENSIVE- colloidal oatmeal cream

AV3630000 Avalon Organics Eczema Relief Intensive by

Drug Labeling and Warnings

AV3630000 Avalon Organics Eczema Relief Intensive by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Water, Aloe Barbadensis Leaf Juice(1), Glycerin, 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, Stearyl Alcohol, Linum Usatatissimum (Linseed) Seed Oil (1), C10-18 Triglycerides, Gluconolactone, Calcium Gluconate, Archidyl Alcohol Arginine, Biosaccharide gum-1, Glyceryl Caprilate, Sodium Anisate, Sodium Levulinate, Behenyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AV3630000 AVALON ORGANICS ECZEMA RELIEF INTENSIVE 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-1300
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-1300-3	89 g in 1 TUBE; Type 0: Not a Combination Product	02/08/2017

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

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

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		117115556	manufacture(61995-1300)