Drug facts

Drug facts
SPL v7
SPL
SPL Set ID 0b427357-b137-4264-9f62-4adaa8b65499
Route
OPHTHALMIC
Published
Effective Date 2020-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextran 70 (1 mg) Hypromellose 2910 (4000 Mpa.s) (3 mg)
Inactive Ingredients
Polidronium Chloride Potassium Chloride Water Sodium Borate Sodium Chloride Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-03-01

Description

Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant

How Supplied

Product: 50090-2352 NDC: 50090-2352-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON


Medication Information

How Supplied

Product: 50090-2352

NDC: 50090-2352-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Description

Active Ingredients Purpose Dextran 70 0.1% Lubricant Hypromellose 2910 0.3% Lubricant

Uses
  • temporary relief of burning and irritation due to dryness of the eye
  • temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • as a protectant against further irritation
Section 50566-9

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 50567-7
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
Section 55105-1
Active Ingredients Purpose
Dextran 70 0.1% Lubricant
Hypromellose 2910 0.3% Lubricant
Warnings

For external use only

Directions
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Questions?

In the U.S. call 1-800-757-9195

(Mon-Fri 9AM-5PM CST)

[email protected]

Other Information
  • store at room temperature
Inactive Ingredients:

POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium borate and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Keep Out of Reach of Children.

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

Dextran 70 and Hypromellose 2910

Structured Label Content

Uses
  • temporary relief of burning and irritation due to dryness of the eye
  • temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • as a protectant against further irritation
Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 50567-7 (50567-7)
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
Section 55105-1 (55105-1)
Active Ingredients Purpose
Dextran 70 0.1% Lubricant
Hypromellose 2910 0.3% Lubricant
Warnings

For external use only

Directions
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Questions?

In the U.S. call 1-800-757-9195

(Mon-Fri 9AM-5PM CST)

[email protected]

How Supplied (HOW SUPPLIED)

Product: 50090-2352

NDC: 50090-2352-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Other Information (Other information)
  • store at room temperature
Inactive Ingredients: (Inactive ingredients:)

POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium borate and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

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.

Dextran 70 and Hypromellose 2910 (dextran 70 and hypromellose 2910)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)