Label: COMFORT- pramoxine shampoo

  • NDC Code(s): 68898-106-01, 68898-106-16
  • Packager: Animal Pharmaceuticals
  • 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 12, 2021

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose

    Pramoxine HCl, USP ……. 1% (w/w) ………Topical Anesthetic

  • PRINCIPAL DISPLAY PANEL

    Comfort Shampoo 16 oz

    Comfort Shampoo 128 oz

  • INGREDIENTS AND APPEARANCE
    COMFORT 
    pramoxine shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68898-106-16474 mL in 1 BOTTLE, PLASTIC
    2NDC:68898-106-013785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2010
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Custom Veterinary Services, Inc. (619511483)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services, Inc.619511483manufacture, api manufacture