Genteal Tears

Genteal Tears
SPL v7
SPL
SPL Set ID a2b715e9-332d-4f0b-b8e5-ebc000681586
Route
OPHTHALMIC
Published
Effective Date 2024-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextran 70 (1 mg) Glycerin (2 mg) Hypromelloses (3 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Glycine Hydrochloric Acid Sodium Hydroxide Magnesium Chloride Polidronium Chloride Polysorbate 80 Potassium Chloride Water Sodium Chloride Zinc Chloride

Identifiers & Packaging

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

Description

Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant

How Supplied

Product: 50090-5050 NDC: 50090-5050-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON


Medication Information

How Supplied

Product: 50090-5050

NDC: 50090-5050-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

Description

Active ingredients Purpose Dextran 70 0.1% Lubricant Glycerin 0.2% Lubricant Hypromellose 0.3% Lubricant

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

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

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 55105-1
Active ingredients Purpose
Dextran 70 0.1% Lubricant
Glycerin 0.2% Lubricant
Hypromellose 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 this 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:

boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD* (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
Keep Out of Reach of Children.

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

Dextran 70, Glycerin, Hypromellose

Structured Label Content

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

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

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 55105-1 (55105-1)
Active ingredients Purpose
Dextran 70 0.1% Lubricant
Glycerin 0.2% Lubricant
Hypromellose 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 this 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: 50090-5050

NDC: 50090-5050-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

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

boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD* (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

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
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, Glycerin, Hypromellose

Advanced Ingredient Data


Raw Label Data

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