EczeNil

Dosage form: cream
Ingredients: OATMEAL 2.3g in 113.2g
Labeler: Healingsmith Institute Inc.
NDC Code: 76066-001

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.

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 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76066-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL2.3 g  in 113.2 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CETYL ALCOHOL 
COCCINIA GRANDIS FRUIT 
PROPYLENE GLYCOL 
AZADIRACHTA INDICA LEAF 
SESAME OIL 
SODIUM LAURYL SULFATE 
METHYLPARABEN SODIUM 
PROPYLPARABEN SODIUM 
STEARIC ACID 
PARAFFIN 
Packaging
#Item CodePackage Description
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/FEIOperations
Nikita Containers Private Limited862345246manufacture

Revised: 10/2011
 
Healingsmith Institute Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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