Label: DETER-X- pramoxine hcl ointment

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 13, 2014

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  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    DETER-X 
    pramoxine hcl ointment
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:53864-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.15 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    DIGLYCERIN (UNII: 3YC120743U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53864-201-1515 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2013
    Labeler - Bock Vet Pharma (078609537)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMS Contract Packaging048602791manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Abbvie Inc078458370api manufacture