Label: PRAMOX-1- pramoxine hcl spray

  • NDC Code(s): 86069-108-08
  • Packager: Stratford Care Usa, Inc.
  • 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 10, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients:

    Pramoxine HCL 1%

  • PURPOSE

    ANTIPRURITIC

  • INDICATIONS & USAGE

    Pramox-1™ Spray is an alcohol-free formulation that can be sprayed directly onto the irritated or raw areas to help relieve itching.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Silicone Emulsion, Polysorbate 20, Stearamidopropyl Dimethylamine Lactate, Carthamus Tinctorius (Safflower) Seed Oil, Sodium Lactate, PEG-75 Lanolin, Hydrolyzed Oats, Fragrance, Methylisothiazolinone.

  • DOSAGE & ADMINISTRATION

    Directions for use: Shake well before use. Spray directly onto affected skin area(s). If necessary, ruffle or part the hair to allow direct contact with the skin. Rub in well. May be used daily or as directed by veterinarian.

  • PRECAUTIONS

    Cautions: For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult a veterinarian. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Keep out of the reach of children.

  • STORAGE AND HANDLING

    Storage: Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    MEDICATED SPRAY

    RELIEF OF ITCHING, FLAKING & IRRITATION

    FOR DOGS, CATS & HORSES

    TROPICAL GUAVA SCENT

    Stratford Animal Care
    A MEMBER OF THE SWEDENCARE FAMILY

    Distributed by:
    StratfordCare USA
    Odessa, FL 33556
    877-498-2002
    www.stratfordrx.com

  • Packaging

    Pramox-108

  • INGREDIENTS AND APPEARANCE
    PRAMOX-1 
    pramoxine hcl spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    OAT (UNII: Z6J799EAJK)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86069-108-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/11/2011
    Labeler - Stratford Care Usa, Inc. (036650469)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

Related Resources

Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!