POLYVINYL ALCOHOL W/POVIDON1.4-0.6%- polyvinyl alcohol, povidon liquid

Polyvinyl Alcohol w/Povidon1.4-0.6% by

Drug Labeling and Warnings

Polyvinyl Alcohol w/Povidon1.4-0.6% by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Polyvinyl Alcohol (1.4%)

Povidone (0.6%)

Purpose

Eye lubricant

Uses

• For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
• May be used as a protectant against further irritation.

Warnings

For use in eyes only. Using this product, to avoid contamination, do not touch tip of container to any surface.

Do not reuse. Once opened, discard after use.

Do not touch single-use container tip to the eye.

Stop use and ask a doctor if

You experience eye pain, changes in vision, continued redness, or irritation of the eye.

The condition worsens or persists for more than 72 hours.

Keep out of reach of children.

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other information

Store at 59°-86° F (15°-30°C)

Use only if single-use container is intact.

Inactive ingredients

Calcium chloride, Hydrochloric acid, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Sodium lactate.

Questions or comments?

Call (888) 969-6855

Do not use

Do not use: If solution changes color or becomes cloudy.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POLYVINYL ALCOHOL W/POVIDON1.4-0.6% 
polyvinyl alcohol, povidon liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1399
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	14 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)
MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1399-92	30 in 1 CARTON	10/01/2023
1		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC: 0536-1399-93	50 in 1 CARTON	10/01/2023
2		0.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	09/19/2023

Labeler - RUGBY LABORATORIES (079246066)