Label: CUTANIA TRISEDTA WIPES- chlorhexidine gluconate cloth
- NDC Code(s): 86145-300-01
- Packager: Vetnova Animal Health LLC
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated April 20, 2022
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INDICATIONS & USAGE
Dermatological cleansing and moisturizing wipes of alkaline pH with inhibitory action against biofilms for dogs, cats, small mammals, and horses. Innovative formula with TrisEDTA (EDTA and Tromethamine) plus chlorhexidine, with the soothing action of glycerin. Highly saturated honeycombed textured fabric for tough cleaning of secretions, exudates and debris.
- DESCRIPTION
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DOSAGE & ADMINISTRATION
Use: Gently rub the affected area with a wipe 1-2 times/day for 7-10 days. Use 1-2 times/week for maintenance. Warnings: For animal and topical use only. Avoid contact with eyes. Wash hands after use. If skin irritation occurs or increases, discontinue use and seek veterinary advice. Keep package tightly closed after each use, in a cool, dry place, protected from the sun and out of reach of children and animals.
Always work with your veterinarian for your animal´s optimal health and well-being.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Wipe Pouch
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INGREDIENTS AND APPEARANCE
CUTANIA TRISEDTA WIPES
chlorhexidine gluconate clothProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86145-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 0.006 mg Inactive Ingredients Ingredient Name Strength Benzyl Alcohol (UNII: LKG8494WBH) 0.05 mg EDETATE DISODIUM (UNII: 7FLD91C86K) Tromethamine (UNII: 023C2WHX2V) TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86145-300-01 24 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/01/2022 Labeler - Vetnova Animal Health LLC (117666944) Registrant - BioPharmaPotentialsl LLC (053465285) Establishment Name Address ID/FEI Business Operations Vetnova Animal Health LLC 117666944 MANUFACTURE