SPL v4
SPL
SPL Set ID ec5cf186-f141-4377-e053-2995a90a6b32
Route
TOPICAL
Published
Effective Date 2022-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol, Unspecified (5 mg)
Inactive Ingredients
Povidone Edetate Sodium Water Benzalkonium Chloride Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-20

Description

Polyvinyl Alcohol Eye Drops 1.4 % w/v


Medication Information

Description

Polyvinyl Alcohol Eye Drops 1.4 % w/v

Use

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

Dose

Instill 1 or 2 drops in the affected eyes as needed

Carton

Warnings

For external use only

Questions

Call. 1-800-103-7321

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use

1.If you are sensitive to any ingredient in this product

2.If solution changes color or becomes cloudy

Eye Lubricant

Eye lubricant

Active Ingredient

Polyvinyl Alcohol Eye Drops 1.4 % w/v

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

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

Stop Use and Ask A Doctor If
  • If you experience eye pain
  • change in vision
  • Continued Redness or irritaion of teh eye
  • Condition worsens or persists for mroe than 72 hours

Keep Out of Reach of Children

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


Structured Label Content

Use

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

Dose

Instill 1 or 2 drops in the affected eyes as needed

Carton

Warnings

For external use only

Questions

Call. 1-800-103-7321

E-mail : [email protected]

Web : www.aurolab.com

Do Not Use (Do not use)

1.If you are sensitive to any ingredient in this product

2.If solution changes color or becomes cloudy

Eye Lubricant (Eye lubricant)

Eye lubricant

Active Ingredient (Active ingredient)

Polyvinyl Alcohol Eye Drops 1.4 % w/v

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
Directions for Use (DIRECTIONS FOR USE)
  • lnstill 1or 2 drops in the affected eye, as needed
Indication & Usage (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

Inactive Ingredient (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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • If you experience eye pain
  • change in vision
  • Continued Redness or irritaion of teh eye
  • Condition worsens or persists for mroe than 72 hours

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)