Label: ECZENIL- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 11, 2011

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  • 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

    Eczenil Carton

  • INGREDIENTS AND APPEARANCE
    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
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