Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15ml (pld)

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15ml (pld)
SPL v2
SPL
SPL Set ID 2653e4fc-4f08-426d-a0a4-31d647c1de56
Route
OPHTHALMIC
Published
Effective Date 2025-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol (1.4 g)
Inactive Ingredients
Sodium Phosphate, Dibasic Dodecahydrate Water Benzalkonium Chloride Edetate Disodium Sodium Phosphate, Monobasic, Dihydrate Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-19

Description

Polyvinyl alcohol 1.4%

Purpose

Lubricant

How Supplied

Product: 50090-7606 NDC: 50090-7606-0 15 mL in a BOTTLE, DROPPER / 1 in a BOX


Medication Information

Purpose

Lubricant

How Supplied

Product: 50090-7606

NDC: 50090-7606-0 15 mL in a BOTTLE, DROPPER / 1 in a BOX

Description

Polyvinyl alcohol 1.4%

Uses
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Warnings

For external use only

Directions
  • instill 1 to 2 drops in the affected eye(s) as needed
Active Ingredient

Polyvinyl alcohol 1.4%

Other Information
  • keep in a dry place
  • store at 15°-25°C (59°-77°F)
  • store away from sources of heat or ignition
Polyvinyl Alcohol
Inactive Ingredients

benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

When Using This Product
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
Do Not Use This Product If
  • solution changes color or becomes cloudy
Keep Out of the Reach of Children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Stop Use and Ask A Doctor If You Experience
  • eye pain
  • changes in vision
  • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Structured Label Content

Uses
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
Purpose

Lubricant

Warnings

For external use only

Directions
  • instill 1 to 2 drops in the affected eye(s) as needed
How Supplied (HOW SUPPLIED)

Product: 50090-7606

NDC: 50090-7606-0 15 mL in a BOTTLE, DROPPER / 1 in a BOX

Active Ingredient (Active ingredient)

Polyvinyl alcohol 1.4%

Other Information (Other information)
  • keep in a dry place
  • store at 15°-25°C (59°-77°F)
  • store away from sources of heat or ignition
Polyvinyl Alcohol (Polyvinyl alcohol)
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

When Using This Product (When using this product)
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.
Do Not Use This Product If (Do not use this product if)
  • solution changes color or becomes cloudy
Keep Out of the Reach of Children. (Keep out of the reach of children.)

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Stop Use and Ask A Doctor If You Experience (Stop use and ask a doctor if you experience)
  • eye pain
  • changes in vision
  • continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Advanced Ingredient Data


Raw Label Data

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