NDC | 62570-100-01, 62570-100-12 |
Set ID | c5ad713b-2d9d-42e9-bd18-44236786b930 |
Category | OTC ANIMAL DRUG LABEL |
Packager | Davis Manufacturing and Packaging Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- Gallon display panel
- 355 ml size
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INGREDIENTS AND APPEARANCE
DAVIS PRAMOXINE ANTI-ITCH
pramoxine lotion/shampooProduct 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