ECZENIL ECZEMA AND DRY SKIN - oatmeal cream
Healingsmith Institute 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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Colloidal Oatmeal 2%

Skin Protectant

Uses
temporarily protects and helps relieve minor skin irritation and itching due to:

eczema
rashes
insect bites
poison ivy, oak or sumac

Warnings
For external use only.

Do not use if you are allergic to sesame oil.

When using this product

do not get into eyes
if you currently use steroids or have used steroids in the recent past, it may take 1 to 3 months to see results

Stop use and ask a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply twice a day or as needed

Other Information

store in a cool and dry place

Inactive Ingredients
BHT, Cetyl Alcohol, Coccinia Indica fruit extract, Fragrance, Holarrhena Atidysenterica leaf extract, Melia Azadirachta leaf extract, Propylene Glycol, Sesamum Indicum (Sesame) seed oil, Sodium Lauryl Sulfate, Sodium Methylparaben, Sodium Propylbaraben, Stearic Acid, White soft paraffin

Eczenil Carton

ECZENIL ECZEMA AND DRY SKIN
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76066-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (OATMEAL)	OATMEAL	2.3 g in 113.2 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE
CETYL ALCOHOL
COCCINIA GRANDIS FRUIT
PROPYLENE GLYCOL
AZADIRACHTA INDICA LEAF
SESAME OIL
SODIUM LAURYL SULFATE
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
STEARIC ACID
PARAFFIN

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:76066-001-04	113.2 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/10/2011

Labeler - Healingsmith Institute Inc. (962842642)

Registrant - Healingsmith Institute Inc. (962842642)

Establishment
Name	Address	ID/FEI	Operations
Nikita Containers Private Limited		862345246	manufacture

Revised: 10/2011 Healingsmith Institute Inc.