Animal NDC 68898-122-16 Pramox Creme Rinse

Pramoxine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 68898-122-16
Proprietary Name Pramox Creme Rinse 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 Hydrochloride 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 Animal Pharmaceuticals
Product Type Otc Animal Drug
Usage Information
    Shake well before using. Apply Creme Rinse evenly over and into the hair coat and rub in well. Rinse well and repeat the procedure if desired. May be used as often as necessary.
Active Ingredient(s)
  • Pramoxine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • CETOSTEARYL ALCOHOL (2DMT128M1S)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (7YC686GQ8F)
  • STEARALKONIUM CHLORIDE (0OUO26BB88)
  • OAT (Z6J799EAJK)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (J2S07SB0YL)
  • POLYSORBATE 60 (CAL22UVI4M)
  • GLYCERIN (PDC6A3C0OX)
  • DIMETHICONE (92RU3N3Y1O)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • SODIUM HYDROXIDE (55X04QC32I)
  • WATER (059QF0KO0R)
  • CETOSTEARYL ALCOHOL (2DMT128M1S)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (7YC686GQ8F)
  • STEARALKONIUM CHLORIDE (0OUO26BB88)
  • OAT (Z6J799EAJK)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (J2S07SB0YL)
  • POLYSORBATE 60 (CAL22UVI4M)
  • GLYCERIN (PDC6A3C0OX)
  • DIMETHICONE (92RU3N3Y1O)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • SODIUM HYDROXIDE (55X04QC32I)
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 Creme Rinse Images

Pramox Creme Rinse 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



Drug Facts




Active Ingredients



Pramoxine HCl, USP 1%


Purpose



Topical Anesthetic


Inactive Ingredients



Water, Cetearyl Alcohol, PEG-40 Hydrogenated Castor Oil, Stearalkonium Chloride, Hydrolyzed Oats, Hydrolyzed Wheat Protein, Polysorbate-60, Glycerin, Dimethicone, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide.


Uses:



a medicated creme rinse for the temporary relief of itching and scratching on dogs, cats and horses with dermatological conditions responsive to pramoxine.


Directions For Use:



Shake well before using. Apply Creme Rinse evenly over and into the hair coat and rub in well. Rinse well and repeat the procedure if desired. May be used as often as necessary.


Precautions



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.


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