OCLUVET NAC NUTRITIONAL LUBRICANT EYE DROPS solution/ drops

OcluVet NAC Nutritional Lubricant Eye Drops by

Drug Labeling and Warnings

OcluVet NAC Nutritional Lubricant Eye Drops by is a Animal medication manufactured, distributed, or labeled by AMBIENCE FAMILY INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Not for use in humans. Keep out of reach of children. Protective gloves should be used and care should be taken when handling the product to avoid skin and eye exposure and accidental ingestion. Accidental exposure may result in skin and eye irritation. Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans.

Warnings: Cease use and consult your veterinarian if the patient experiences eye redness or discomfort for more than 72 hours.Do not use if seal is broken. Do not touch the bottle tip to any surface during application. Do not share this container or the contents with others. Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions: Shake well before each use.Apply drop to the eye 3 times per day for 6 to 8 weeks or as directed by your veterinarian. To maintain ocular clarity, aooly 1 drop to the eye per day. See package insert for additional information.

ACTIVE INGREDIENT

N-Acetyl-L-Carnosine

INACTIVE INGREDIENT

Ingredients: Purified Water,Sodium Hydrogen Carbonate (as a buffering agent), N-Acetyl-L-Carnosine, purifiedL Carnosine, Glutathione, Cysteine Ascorbate, L-Taurine, Riboflavin Monophosphate, PropyleneGlycol(0.2%)

WARNINGS AND PRECAUTIONS

Not for use in humans. Keep out of reach of children. Protective gloves should be used and care should be taken when handling the product to avoid skin and eye exposure and accidental ingestion. Accidental exposuremay result in skin and eye irritation. Accidental ingestion may cause gastrointestinal disturbances and hypersensitivity reactions in humans.

PRINCIPAL DISPLAY PANEL

Directions: Shake well before each use.Apply drop to the eye 3 times per day for 6 to 8 weeks or as directed by your veterinarian. To maintain ocular clarity, aooly 1 drop to the eye per day. See package insert for additional information. Ingredients: Purified Water,Sodium Hydrogen Carbonate (as a buffering agent), N-Acetyl-L-Carnosine, purifiedL Carnosine, Glutathione, Cysteine Ascorbate, L-Taurine, Riboflavin Monophosphate, PropyleneGlycol(0.2%) Warnings: Cease use and consult your veterinarian if the patient experiences eye redness or discomfort for more than 72 hours.Do not use if seal is broken. Do not touch the bottle tip to any surface during application. Do not share this container or the contents with others. Keep out of reach of children.

The labeling shows as below:

INGREDIENTS AND APPEARANCE

OCLUVET NAC NUTRITIONAL LUBRICANT EYE DROPS 
ocluvet nac nutritional lubricant eye drops solution/ drops

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86202-0090
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
N-ACETYLCARNOSINE (UNII: 0TPN86OQIF) (N-ACETYLCARNOSINE - UNII:0TPN86OQIF)	N-ACETYLCARNOSINE	1 mg  in 16 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARNOSINE (UNII: 8HO6PVN24W)
GLUTATHIONE (UNII: GAN16C9B8O)
CYSTEINE (UNII: K848JZ4886)
CALCIUM ASCORBATE (UNII: 183E4W213W)
TAURINE (UNII: 1EQV5MLY3D)
RIBOFLAVIN (UNII: TLM2976OFR)
RIBOFLAVIN SODIUM (UNII: 04SRR95RP8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86202-0090-1	16 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2024

Labeler - AMBIENCE FAMILY INC (084561491)

Establishment
Name	Address	ID/FEI	Business Operations
AMBIENCE FAMILY INC		084561491	manufacture, api manufacture