Ophthavet Complete Gel by Excelvision / Bloomage Biotechnology corp., Ltd. Ophthavet Complete Gel

Ophthavet Complete Gel by

Drug Labeling and Warnings

Ophthavet Complete Gel by is a Animal medication manufactured, distributed, or labeled by Excelvision, Bloomage Biotechnology corp., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OPHTHAVET COMPLETE GEL- hyaluronate sodium solution 
Excelvision

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.

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Ophthavet Complete Gel

0.2% Viscoadapative Sodium Hyaluronate
+ Hydrating Lipid

CONTAINS:

Purified water, phosphorylcholine polymer, sodium chloride, glycerol, sodium dihydrogen phosphate, sodium hyaluronate, disodium phosphate, sodium hydroxide

INDICATIONS:

For use as a lubricant to prevent further irritation, or to relieve dryness of the eye. For use in dogs and cats.

CAUTION:
If condition worsens, discontinue use and consult veterinarian. Keep container tightly closed. To avoid contamination, do not touch tip of container to any surface including the eye, the eyelid or your finngers. Replace cap after using. To minimize the risk of infection, DO NOT use beyond the expiry date on the label. Do not use if safety seal is broken. Do not use if cloudy or discolored.

DIRECTIONS:

Apply to the eye as directed by your veterinarian. OPHTHAVET Complete Ophthalmic Gel provides blink-activated lubrication and moistening for the eye surface during the day or night.

Wash hands before use.
Tilt the animal’s head up slightly and pull the lower eyelid down to create a small area to apply the drop.
While holding the bottle above the eye, press gently to release one drop onto the eye.
Repeat the process in the other eye, if needed.
After application, shake any remaining droplet from the tip of bottle and replace cap securely. This will help to prevent contamination of the bottle.
Can be applied as often as directed by your veterinarian.
If you are applying any other eye drops or ointments, wait at least 15 minutes between each application.

KEEP TIGHTLY CLOSED STORE AT 2 - 25°C (36 - 77°F).

WARNING:

KEEP OUT OF REACH OF CHILDREN.

NOT FOR USE IN HUMANS.

HOW SUPPLIED:

OPHTHAVET Complete Ophthalmic Gel is supplied in a bottle with a fill volume of 10 mL (0.33 fl oz). Contents are sterile and preservative-free.

Package Labeling:

OPHTHAVET COMPLETE GEL 
hyaluronate sodium solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 81372-046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81372-046-10	1 in 1 BOX
1		10 mL in 1 BOTTLE; Number of Units = 1

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2021	09/01/2021

Labeler - Excelvision (274234566)

Establishment
Name	Address	ID/FEI	Business Operations
Bloomage Biotechnology corp., Ltd.		530385772	api manufacture

Revised: 10/2021

Document Id: 3603f4be-2499-4c6a-9098-f19ed894508e

50577-6

Set id: 5be126ae-d4a7-4281-9d99-781ca26eefc3

Version: 2

Effective Time: 20211022