Label: ABELIA SMALL PET OTIC- zinc gluconate solution/ drops
- NDC Code(s): 86145-200-01
- 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 August 18, 2021
If you are a consumer or patient please visit this version.
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VETERINARY INDICATIONS
Antimicrobial, drying, deodorizing, soothing and protective otic solution for rabbits, ferrets and other small mammals. Ideal for very sensitive ears especially in pocket pets, exotic mammals, kittens, puppies and small breeds of dogs and cats. Can be used alone or with other therapeutic agents.
Gentle aqueous treatment for acute and chronic yeast infections including Malassezia spp. Relieves itching and calms irritation. Restores healthy environment of ear canal. Nourishes and replenishes epithelium to favor healing. Helps dry and freshen ear canal. Does not interfere with allergy tests. Stain and oil free on fur, pets beds and furniture. Antibiotic and corticosteriod free.
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INDICATIONS & USAGE
Indications: for initial and maintenance treatment of ear canals with yeast adnd Malassezia spp. otitis, disrupted epithelium, and excess debilitating moisture. For regenerating ear canal epithelium after treatment of ear mites in rabbits, ferrets and kittens. Safe for frequent and long-term use. Safe for use with perforated tympanic membrane.
- DOSAGE & ADMINISTRATION
- DESCRIPTION
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PRECAUTIONS
Cautions: for animal and topical use only. Avoid contact with eyes. If irritation develops or increases discontinue use and consult your veterinarian. Keep out of reach of children and animals. Store at room temperature.
Always work with your veterinarian for your animals optimal health and well-being.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 59 ml Bottle Box
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INGREDIENTS AND APPEARANCE
ABELIA SMALL PET OTIC
zinc gluconate solution/ dropsProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86145-200 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength zinc gluconate (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) zinc gluconate 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Boric Acid (UNII: R57ZHV85D4) 1 mg in 1 mL LYSINE (UNII: K3Z4F929H6) taurine (UNII: 1EQV5MLY3D) WATER (UNII: 059QF0KO0R) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86145-200-01 1 in 1 BOX 1 59 mL in 1 BOTTLE, DISPENSING Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 08/21/2021 Labeler - Vetnova Animal Health LLC (117666944) Registrant - BioPharmaPotentialsl LLC (053465285) Establishment Name Address ID/FEI Business Operations Vetnova Animal Health LLC 117666944 RELABEL