Label: PRAMOXINE ANTI ITCH- pramoxine hydrochloride shampoo
- NDC Code(s): 62570-101-01, 62570-101-12
- Packager: Davis Manufacturing and Packaging Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 6, 2019
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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
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRAMOXINE ANTI ITCH
pramoxine hydrochloride shampooProduct 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