PRAMOXINE ANTI ITCH- pramoxine hydrochloride shampoo

Pramoxine Anti Itch by

Drug Labeling and Warnings

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 Shampoo helps to provide rapid, temporary relief from pruritis caused by a variety of dermatologic conditions. The safe, fast acting formula contains 1% Pramoxine Hydrochloride which acts as an effective topical agent to aid in alleviating itching and discomfort. Colloidal Oatmeal and moisture-rich emollients condition the skin and help prevent future dryness and flaking while Omega-6 fatty acids provide dermal nourishing. Davis Pramoxine Anti-Itch Shampoo is gentle enough for frequent use and leaves the coat with a healthy shine and pleasant scent.

SPL UNCLASSIFIED SECTION

Environment Friendly

MADE IN THE USA

Davis Manufacturing

541 Proctor Avenue

Atlanta/Scottdale, GA 30079

www.davismfg.com

800-292-2424

ACTIVE INGREDIENT

Active Ingredients: Pramoxine Hydrochloride 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: Purified Water, Cetyl Alcohol, Cetearyl Alcohol & Ceterimenium Bromide, Modified Acrylic Polymer, Germaben II, Cationic Guar Gum, Colloidal Oatmeal, Triethenolamine, Herbal Fragrance, FD&C Yellow #5, Chocolate Dye

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE

Wet coat thoroughly with warm water.  Apply shampoo to head ears, then lather.  Do not get shampoo into eyes or nose.  Repeat procedure with neck, chest, middle and hindquarters, finishing with legs.  Allow shampoo to be absorbed for 5 to 10 minutes then rinse thoroughly.  May be used as often as necessary or as directed by a veterinarian.  For optimal results, use in conjunction with Davis Pramoxine Anti-Itch TM Creme Rinse.  For added benefit between baths, apply Pramoxine Anti-Itch TM Spray to localized areas.

PRECAUTIONS

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

KEEP OUT OF REACH OF CHILDREN

For External Use Only

Keep Out of Reach of Children

PRINCIPAL DISPLAY PANEL

Davis Veterinary Products
Pramoxine Anti-Itch TM Shampoo
With 1% Pramoxine Hydrochloride
For Dogs, Cats, Puppies and Kittens
Anti-pruritic formula alleviates scratching and flaking associated with seborrhea dermatitis and other skin disorders

12 Fl. Oz. (355 ml)

Davis

Veterinary Products

Pramoxine

Anti-Itch TM

Shampoo

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)

INGREDIENTS AND APPEARANCE

PRAMOXINE ANTI ITCH 
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 62570-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
OATMEAL (UNII: 8PI54V663Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62570-101-12	355 g in 1 BOTTLE
2	NDC: 62570-101-01	3785 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/14/2017

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