PRAMOXINE ANTI ITCH- pramoxine hydrochloride shampoo 
Davis Manufacturing and Packaging Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Pramoxine Anti-Itch Shampoo

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.

Environment Friendly

MADE IN THE USA

Davis Manufacturing

541 Proctor Avenue

Atlanta/Scottdale, GA 30079

www.davismfg.com

800-292-2424

Active Ingredients: Pramoxine Hydrochloride 1.0%

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

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.

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

For External Use Only

Keep Out of Reach of Children

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)

PSH12

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)

PSHG

PRAMOXINE ANTI ITCH 
pramoxine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62570-101-12355 g in 1 BOTTLE
2NDC:62570-101-013785 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/14/2017
Labeler - Davis Manufacturing and Packaging Inc (106680523)
Registrant - Vanessa Solis (106680523)
Establishment
NameAddressID/FEIBusiness Operations
Davis Manufacturing and Packaging Inc106680523api manufacture

Revised: 11/2019
Document Id: ff256c49-5712-4355-ab79-ce33e0d1bf79
Set id: 2b846bf6-eb1f-4934-8f4d-5ad65e19db90
Version: 3
Effective Time: 20191106
 
Davis Manufacturing and Packaging Inc