POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V for solution

Polyvinyl Alcohol Eye Drops 1,4 % w/v by

Drug Labeling and Warnings

Polyvinyl Alcohol Eye Drops 1,4 % w/v by is a Otc medication manufactured, distributed, or labeled by Aurolab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Polyvinyl Alcohol Eye Drops 1.4 % w/v

DIRECTIONS FOR USE

• lnstill 1or 2 drops in the affected eye, as needed

INACTIVE INGREDIENT

1.Boric acid

2.Calcium chloride

3.Glycerin
4.Magnesium chloride

5.Mannitol

6.Potassium chloride

7.Purified water

8.Stablized oxy cholro complex

9.Sodium tetra borate
10.Sodium hyaluronate

11.Sodium citrate

Tamper Protection

• For your protection a tamper evident ring is attached to the bottlecap
• Upon opening, this will separate from the cap and can be discarded
• Use only if this ring is present and attached when the bottle is first opened

Use

For use as a lubricant to prevent further irritation or to relieve dryness of the eye

Questions

Call. 1-800-103-7321
E-mail : info@aurolab.com
Web : www.aurolab.com

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if

1. If you experience eye pain
2. change in vision
3. Continued Redness or irritaion of teh eye
4. Condition worsens or persists for mroe than 72 hours

Do not use

1.If you are sensitive to any ingredient in this product
2.If solution changes color or becomes cloudy

Warnings

For external use only

Indication & usage

Do not touch the nozzle tip to any surface since this may contaminate the solution
Remove contact lenses before use Should not use at the same time as other ophthalmic drugs
Replace cap after using

Dose

Instill 1 or 2 drops in the affected eyes as needed

Eye lubricant

Eye lubricant

Carton

INGREDIENTS AND APPEARANCE

POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V 
polyvinyl alcohol eye drops 1,4 % w/v for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16030-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16030-201-10	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	09/20/2022

Labeler - Aurolab (677319965)

Establishment
Name	Address	ID/FEI	Business Operations
Aurolab		677319965	manufacture(16030-201)