ECZENIL - colloidal 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:

Warnings
For external use only.

Do not use if you are allergic to sesame oil.

When using this product

Stop use and ask a doctor if

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

Directions

Other Information

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 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76066-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2.3 g  in 113.2 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76066-001-04113.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/02/2012
Labeler - Healingsmith Institute Inc. (962842642)
Registrant - Healingsmith Institute Inc. (962842642)
Establishment
NameAddressID/FEIBusiness Operations
Nikita Containers Private Limited862345246manufacture

Revised: 10/2011
Document Id: fdc5f262-151b-45ae-8e5c-c4ba982495a6
Set id: 9f211875-4ffb-493d-a011-40c3a2b86615
Version: 4
Effective Time: 20111011
 
Healingsmith Institute Inc.