VIVA - polysorbate 80 solution/ drops
Dakota Laboratories, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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.

• 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.

• 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.

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

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

VIVA
polysorbate 80 solution/ drops

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	02/19/1987

Labeler - Dakota Laboratories, LLC (002303871)

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