Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6018a680-374a-407c-9ef9-f5b01286383d
Route
OPHTHALMIC
Published
Effective Date 2012-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycols (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Hydrochloric Acid Potassium Chloride Water Sodium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-01-11

Description

Polyethylene Glycol 400 0.4% Propylene Glycol 0.3%

Purpose

Lubricant Lubricant


Medication Information

Purpose

Lubricant

Lubricant

Description

Polyethylene Glycol 400 0.4% Propylene Glycol 0.3%

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation


Section 51945-4

Lubricant Eye Drops Ultra

Warnings

Enter section text here

Directions
  • Put 1 to 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor

Other Information

Store at 15 - 30ºC (59 - 86ºF)

Active Ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Inactive Ingredients

benzalkonium chloride, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide

When Using This Product
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

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 lasts more than 72 hours

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 burning and irritation due to dryness of the eye
  • for protection against further irritation


Section 51945-4 (51945-4)

Lubricant Eye Drops Ultra

Purpose

Lubricant

Lubricant

Warnings

Enter section text here

Directions
  • Put 1 to 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor

Other Information (Other information)

Store at 15 - 30ºC (59 - 86ºF)

Active Ingredients (Active ingredients)

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide

When Using This Product (When using this product)
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

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 lasts more than 72 hours

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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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