DAVIS PRAMOXINE ANTI-ITCH- pramoxine lotion/shampoo

Davis Pramoxine Anti-Itch by

Drug Labeling and Warnings

Davis Pramoxine Anti-Itch by is a Animal medication manufactured, distributed, or labeled by Davis Manufacturing and Packaging Inc, Vanessa Solis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Davis Pramoxine Anti-ItchTM Creme Rinse helps to provide rapid, temporary relief from pruitis caused by a variety of dermatologic conditions while renourishing the skin and leaving the coat more manageable.  The safe, fast-acting formula contains 1% Pramoxine Hydrochloride which acts as an effective topical agent that aids in alleviating itching and discomfort.  Colloidal Oatmeal and moisture-rich emollients condition and nourish the skin and help prevent future dryness and flaking.

SPL UNCLASSIFIED SECTION

Made in the USA

Manufactured by:

Davis Manufacturing 

541 Proctor Avenue

Scottdale, GA 30079

www.davismfg.com

ACTIVE INGREDIENT

Active Ingredient: Pramoxine Hydrochloride 1.0%

INACTIVE INGREDIENT

Inactive Ingredients:  Purified Water, Cetyl Alcohol, Cetearyl Alcohol & Cetrimonium Bromide, Modified Acrylic Polymer, Germaben II, Cationic Guar Gum, FD&C Yellow #5, Chocolate Dye

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE

After shampooing and thoroughly rinsing, aplly creme rinse over the entire coat.  Rub in Well.  Do not get into eyes or nose.  Allow creme rinse to be absorbed for 5 to 10 minutes before lightly rinsing.  For residual results, do not rinse and use as a leave on conditioner.  May be used as often as necessary or as directed by a veterinarian.

PRECAUTIONS

If contact with eyes or nose occurs, rinse thoroughly.  If irritation or redness presists or increases, discontinue use and consult a veterinarian.

For External Use Only

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach

of Children and Pets

Gallon display panel

Davis Veterinary Products

Pramoxine

Anti-ItchTM

Creme Rinse

With 1% Pramoxine Hydrochloride

For Dogs, Cats, Puppies and Kittens

Anti-pruritic formula alleviates

scratching and flaking associated with 

seborrhea dermititis and other skin disorders.

1 Gallon (3.785 Liters)

355 ml size

Davis Veterinary Products

Pramoxine

Anti-ItchTM

Creme Rinse

With 1% Pramoxine Hydrochloride

For Dogs, Cats, Puppies and Kittens

Anti-pruritic formula alleviates

scratching and flaking associated with

seborrhea dermititis and other skin disorders.

12 Fl. Oz. (355 ml)

INGREDIENTS AND APPEARANCE

DAVIS PRAMOXINE ANTI-ITCH 
pramoxine lotion/shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 62570-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 45:10:45; 1200000 MW) (UNII: F11YNO8FDQ)
CETRIMONIUM BROMIDE (UNII: L64N7M9BWR)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
oatmeal (UNII: 8PI54V663Y)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62570-100-12	355 g in 1 BOTTLE
2	NDC: 62570-100-01	3785 g in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/03/2018

Labeler - Davis Manufacturing and Packaging Inc (106680523)

Registrant - Vanessa Solis (106680523)

Establishment
Name	Address	ID/FEI	Business Operations
Davis Manufacturing and Packaging Inc		106680523	api manufacture