VIVA- polysorbate 80 solution/ drops

Viva by

Drug Labeling and Warnings

Viva by is a Otc medication manufactured, distributed, or labeled by Dakota Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Polysorbate 80 (1.0%)

Purpose

Eye Lubricant

Keep out of reach of children

Keep this and all drugs out of the reach of children.

INDICATIONS & USAGE

Temporarily relieves burning and irritation due to dryness of the eye.
Temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.
Protects against further irritation or relieves dryness of the eye.
Lubricates to prevent further irritation or to relieve dryness of the eye.

WARNINGS

To avoid contamination, do not touch tip of container to any surface.

Replace cap after using

If you experience pain, changes in vision, continued redness or irritation of the eye, or if the condition persists for more than 72 hours, discontinue use and consult a doctor.

If solution changes color or becomes cloudy, do not use.

DOSAGE & ADMINISTRATION

Instill 1 or 2 drops in the affected eye(s) as needed.

INACTIVE INGREDIENT

purified water, sodium chloride, citric acid, edetate disodium with retinyl palmitate, mannitol, sodium citrate, and pyruvate as antioxidants.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VIVA 
polysorbate 80 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54891-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polysorbate 80 (UNII: 6OZP39ZG8H) (Sorbitan - UNII:6O92ICV9RU)	Polysorbate 80	100 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)	60.5 mg  in 10 mL
Citric Acid (UNII: 2968PHW8QP)	.34 mg  in 10 mL
Edetate Disodium (UNII: 7FLD91C86K)	5 mg  in 10 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	5.5 mg  in 10 mL
Mannitol (UNII: 3OWL53L36A)	18 mg  in 10 mL
Sodium Citrate (UNII: 1Q73Q2JULR)	73.6 mg  in 10 mL
Sodium Pyruvate (UNII: POD38AIF08)	5 mg  in 10 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54891-001-02	10 mL in 1 BOTTLE
2	NDC: 54891-001-04	.5 mL in 1 VIAL, SINGLE-USE
3	NDC: 54891-001-03	.5 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/19/1987

Labeler - Dakota Laboratories, LLC (002303871)

Establishment
Name	Address	ID/FEI	Business Operations
Dakota Laboratories, LLC		002303871	manufacture