Animal NDC 86069-109-01 Pramox-1

Pramoxine Hcl

Animal Product Information

Field Name Field Value
Animal NDC Code 86069-109-01
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™ Shampoo is a gentle cleansing formulation for dogs, cats and horses. Pramox-1™ Shampoo contains pramoxine and micronized colloidal oatmeal for the temporary relief of itching, flaking, and irritation.
Active Ingredient(s)
  • Pramoxine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • SODIUM CHLORIDE (451W47IQ8X)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • OATMEAL (8PI54V663Y)
  • SAFFLOWER OIL (65UEH262IS)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • SODIUM CHLORIDE (451W47IQ8X)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • OATMEAL (8PI54V663Y)
  • SAFFLOWER OIL (65UEH262IS)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • 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™ Shampoo is a gentle cleansing formulation for dogs, cats and horses. Pramox-1™ Shampoo contains pramoxine and micronized colloidal oatmeal for the temporary relief of itching, flaking, and irritation.


Inactive Ingredient



Inactive Ingredients: Water, Sodium C14-16 Olefin Sulfonate, Disodium Cocoamphodiacetate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Hydrolyzed Oats, Carthamus tinctorius (Safflower) Seed Oil, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone


Dosage & Administration



Directions for use: Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.


Precautions



Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.


Storage And Handling



Storage: Store at controlled room temperature.


Other



MEDICATED SHAMPOO

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.