Animal NDC 86069-108-08 Pramox-1

Pramoxine Hcl

Animal Product Information

Field Name Field Value
Animal NDC Code 86069-108-08
Proprietary Name Pramox-1 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pramoxine Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Stratford Care Usa, Inc.
Product Type Otc Animal Drug
Usage Information
    Pramox-1™ Spray is an alcohol-free formulation that can be sprayed directly onto the irritated or raw areas to help relieve itching.
Active Ingredient(s)
  • Pramoxine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • POLYSORBATE 20 (7T1F30V5YH)
  • STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (31Q9363QSX)
  • SAFFLOWER OIL (65UEH262IS)
  • SODIUM LACTATE (TU7HW0W0QT)
  • PEG-75 LANOLIN (09179OX7TB)
  • OAT (Z6J799EAJK)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • GLYCERIN (PDC6A3C0OX)
  • POLYSORBATE 20 (7T1F30V5YH)
  • STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (31Q9363QSX)
  • SAFFLOWER OIL (65UEH262IS)
  • SODIUM LACTATE (TU7HW0W0QT)
  • PEG-75 LANOLIN (09179OX7TB)
  • OAT (Z6J799EAJK)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Pramox-1 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



Active Ingredients:

Pramoxine HCL 1%


Otc - 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.


Other



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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.