Label: VIVA- polysorbate 80 solution/ drops
Contains inactivated NDC Code(s)
NDC Code(s): 54891-001-02, 54891-001-03, 54891-001-04
- Packager: Dakota Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 25, 2012
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- Active ingredients
- Keep out of 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.
• 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
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