Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID a2992597-3490-6a5c-be45-2b6fa15e1547
Route
OPHTHALMIC
Published
Effective Date 2023-12-15
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


Medication Information

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.

Principal Display Panel

NDC  0065-0426-36



Moderate DRY EYE SYMPTOM RELIEF



GenTeal® Tears

LUBRICANT EYE DROPS



LIQUID DROPS

Fast Soothing Relief



PREVIOUSLY TEARS NATURALE® FORTE



STERILE 15 mL (0.5 FL OZ)



Alcon



TAMPER EVIDENT:

For your protection, this bottle has an

imprinted seal around the neck. Do

not use if seal is damaged or missing

at time of purchase.



Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



Country of Origin: USA



300048636-0621

NDC  0065-0426-37



TWIN PACK



Moderate DRY EYE SYMPTOM RELIEF



GenTeal® Tears

LUBRICANT EYE DROPS



LIQUID DROPS

Fast Soothing Relief



STERILE Two 15 mL (0.5 FL OZ) bottles each



Alcon



TAMPER EVIDENT:

For your protection, this bottle has an

imprinted seal around the neck. Do

not use if seal is damaged or missing

at time of purchase.



Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



Country of Origin: USA



©2017 Alcon Inc.



9017786-0819

NDC 0065-0426-36

Moderate DRY EYE SYMPTOM RELIEF



GenTeal® Tears

LUBRICANT EYE DROPS



LIQUID DROPS

Fast Soothing Relief

STERILE 15 ml (0.5 FL OZ)



STERILE-FOR TOPICAL EYE USE ONLY

Uses: For the temporary relief of burning and irritation due to dryness of the eye and for use as a protectant against further irritation. For the temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun. Directions: put 1 or 2 drops in the affected eye(s) as needed.



Warnings: If solution changes color or becomes cloudy, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Keep this and all drugs out of the reach of children. See carton for complete Warnings.



INGREDIENTS: Each mL contains: Active: Dextran 70 0.1%, Glycerin 0.2% and Hypromellose 0.3%. Preservative: POLYQUAD* (polyquaternium-1) 0.001%. Inactives: boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.



TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time or purchase.



Store at room temperature.



Alcon

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



LOT:     EXP:



300048635-0621

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.


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]

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC  0065-0426-36



Moderate DRY EYE SYMPTOM RELIEF



GenTeal® Tears

LUBRICANT EYE DROPS



LIQUID DROPS

Fast Soothing Relief



PREVIOUSLY TEARS NATURALE® FORTE



STERILE 15 mL (0.5 FL OZ)



Alcon



TAMPER EVIDENT:

For your protection, this bottle has an

imprinted seal around the neck. Do

not use if seal is damaged or missing

at time of purchase.



Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



Country of Origin: USA



300048636-0621

NDC  0065-0426-37



TWIN PACK



Moderate DRY EYE SYMPTOM RELIEF



GenTeal® Tears

LUBRICANT EYE DROPS



LIQUID DROPS

Fast Soothing Relief



STERILE Two 15 mL (0.5 FL OZ) bottles each



Alcon



TAMPER EVIDENT:

For your protection, this bottle has an

imprinted seal around the neck. Do

not use if seal is damaged or missing

at time of purchase.



Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



Country of Origin: USA



©2017 Alcon Inc.



9017786-0819

NDC 0065-0426-36

Moderate DRY EYE SYMPTOM RELIEF



GenTeal® Tears

LUBRICANT EYE DROPS



LIQUID DROPS

Fast Soothing Relief

STERILE 15 ml (0.5 FL OZ)



STERILE-FOR TOPICAL EYE USE ONLY

Uses: For the temporary relief of burning and irritation due to dryness of the eye and for use as a protectant against further irritation. For the temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun. Directions: put 1 or 2 drops in the affected eye(s) as needed.



Warnings: If solution changes color or becomes cloudy, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Keep this and all drugs out of the reach of children. See carton for complete Warnings.



INGREDIENTS: Each mL contains: Active: Dextran 70 0.1%, Glycerin 0.2% and Hypromellose 0.3%. Preservative: POLYQUAD* (polyquaternium-1) 0.001%. Inactives: boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.



TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time or purchase.



Store at room temperature.



Alcon

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA



LOT:     EXP:



300048635-0621

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.


Advanced Ingredient Data


Raw Label Data

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