Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 8bcc8882-b886-4b55-9bc4-d4b92a41358f
Route
OPHTHALMIC
Published
Effective Date 2022-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose, Unspecified (3 mg) Povidone, Unspecified (5 mg)
Inactive Ingredients
Alginic Acid Anhydrous Citric Acid Boric Acid Camphor (synthetic) Chlorobutanol Edetate Disodium Racementhol Polysorbate 80 Water Sodium Borate Sodium Citrate, Unspecified Form Taurine Zinc Sulfate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Hypromellose 0.3% Povidone 0.5%

Purpose

Hypromellose – Lubricant Povidone - Lubricant


Medication Information

Purpose

Hypromellose – Lubricant

Povidone - Lubricant

Description

Hypromellose 0.3% Povidone 0.5%

Uses
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • protects against further irritation or to relieve dryness of the eye
Warnings

For external use only

Directions
  • put 1 or 2 drops in the affected eye(s) as needed
  • tightly snap on cap to seal

Other information

  • do not store above 25 OC (77 OF)
Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Active Ingredient

Hypromellose 0.3%

Povidone 0.5%

Inactive Ingredients

alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

Principal Display Panel
When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • do not use if solution changes color or becomes cloudy
Stop Use and Ask A Doctor If
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes lasts
  • condition worsens or persists for more 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

Uses
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • protects against further irritation or to relieve dryness of the eye
Purpose

Hypromellose – Lubricant

Povidone - Lubricant

Warnings

For external use only

Directions
  • put 1 or 2 drops in the affected eye(s) as needed
  • tightly snap on cap to seal

Other information

  • do not store above 25 OC (77 OF)
Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Active Ingredient (Active ingredient)

Hypromellose 0.3%

Povidone 0.5%

Inactive Ingredients (Inactive ingredients)

alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

Principal Display Panel
When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • do not use if solution changes color or becomes cloudy
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eyes lasts
  • condition worsens or persists for more 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

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