Label: PRAMOX-1- pramoxine hcl shampoo
- NDC Code(s): 86069-109-01, 86069-109-12, 86069-109-16
- Packager: Stratford Care Usa, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 10, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Directions for use: Shake well before use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.
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PRECAUTIONS
Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
PRAMOX-1
pramoxine hcl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-109 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LACTATE (UNII: TU7HW0W0QT) OATMEAL (UNII: 8PI54V663Y) SAFFLOWER OIL (UNII: 65UEH262IS) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86069-109-12 355 mL in 1 BOTTLE, PLASTIC 2 NDC:86069-109-01 3785 mL in 1 BOTTLE, PLASTIC 3 NDC:86069-109-16 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/11/2011 Labeler - Stratford Care Usa, Inc. (036650469)
