DAVIS PRAMOXINE ANTI-ITCH- pramoxine lotion/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 Creme Rinse With 1% Pramoxine Hydrochloride

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.

Made in the USA

Manufactured by:

Davis Manufacturing 

541 Proctor Avenue

Scottdale, GA 30079

www.davismfg.com

Active Ingredient: Pramoxine Hydrochloride 1.0%

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

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.

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 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)

Gallon

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)

355 ml

DAVIS PRAMOXINE ANTI-ITCH 
pramoxine lotion/shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:62570-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62570-100-12355 g in 1 BOTTLE
2NDC:62570-100-013785 g in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/03/2018
Labeler - Davis Manufacturing and Packaging Inc (106680523)
Registrant - Vanessa Solis (106680523)
Establishment
NameAddressID/FEIBusiness Operations
Davis Manufacturing and Packaging Inc106680523api manufacture

Revised: 4/2018
Document Id: 932f0832-bf8e-44d5-994b-c462ef4ec175
Set id: c5ad713b-2d9d-42e9-bd18-44236786b930
Version: 1
Effective Time: 20180427
 
Davis Manufacturing and Packaging Inc