OTC Medication Information: GenTeal Tears (Moderate)

GENTEAL TEARS (MODERATE) — dextran 70, glycerin and hypromelloses solution/ drops
A-S Medication Solutions

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Warnings

For external use only

Do not use

  • if this solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

  • 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 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

Keep out of reach of children.

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

Directions

  • put 1 or 2 drops in the affected eye(s) as needed

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.

HOW SUPPLIED

Product: 50090-5050

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

Questions?

In the U.S. call 1-800-757-9195
(Mon-Fri 9AM-5PM CST)
alcon.medinfo@alcon.com

Dextran 70, Glycerin, Hypromellose

Label ImageLabel Image
GENTEAL TEARS (MODERATE)
dextran 70, glycerin, hypromellose solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5050(NDC:0065-0426)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTRAN 70 (DEXTRAN 70) DEXTRAN 70 1 mg in 1 mL
GLYCERIN (GLYCERIN) GLYCERIN 2 mg in 1 mL
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid
Calcium Chloride
Glycine
Hydrochloric Acid
Sodium Hydroxide
Magnesium Chloride
Polidronium Chloride
Polysorbate 80
Potassium Chloride
Water
Sodium Chloride
Zinc Chloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5050-0 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (50090-5050-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 03/01/2016
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5050)

Revised: 04/2021 A-S Medication Solutions

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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