ECZENIL- colloidal oatmeal cream

EczeNil by

Drug Labeling and Warnings

EczeNil by is a Otc medication manufactured, distributed, or labeled by Healingsmith Institute Inc., Nikita Containers Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Colloidal Oatmeal 2%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

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

• eczema
• rashes
  
• insect bites
  
• poison ivy, oak or sumac

WARNINGS

Warnings
For external use only.

DO NOT USE

Do not use if you are allergic to sesame oil.

WHEN USING

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

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

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

DOSAGE & ADMINISTRATION

Directions

• apply twice a day or as needed

STORAGE AND HANDLING

Other Information

• store in a cool and dry place

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECZENIL 
colloidal oatmeal cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2.3 g  in 113.2 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
SESAME OIL (UNII: QX10HYY4QV)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
STEARIC ACID (UNII: 4ELV7Z65AP)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76066-001-04	113.2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/02/2012

Labeler - Healingsmith Institute Inc. (962842642)

Registrant - Healingsmith Institute Inc. (962842642)

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