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Name:Viva
Manufacturer:Dakota Laboratories, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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.

image of box


VIVA 
polysorbate 80 solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54891-001(NDC:54891)
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polysorbate 80 (Sorbitan ) Polysorbate 80 100 mg  in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
SODIUM CHLORIDE 60.5 mg  in 10 mL
Citric Acid .34 mg  in 10 mL
Edetate Disodium 5 mg  in 10 mL
VITAMIN A PALMITATE 5.5 mg  in 10 mL
Mannitol 18 mg  in 10 mL
Sodium Citrate 73.6 mg  in 10 mL
Sodium Pyruvate 5 mg  in 10 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54891-001-02 10 mL in 1 BOTTLE None

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 Operations
Dakota Laboratories, LLC 002303871 manufacture

Revised: 04/2011 Dakota Laboratories, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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