Label: GENTEAL TEARS (MODERATE)- dextran 70, glycerin, hypromellose solution/ drops
- NDC Code(s): 0065-0426-36, 0065-0426-37
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 29, 2022
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- ACTIVE INGREDIENT
- Uses
- Warnings
- Do not use
- When using this product
- STOP USE
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients:
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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 0065-0426-36
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
a Novartis company
Country of Origin: USA
© 2015 Novartis
*trademark of Novartis -
INGREDIENTS AND APPEARANCE
GENTEAL TEARS (MODERATE)
dextran 70, glycerin, hypromellose solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0426 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 70 1 mg in 1 mL Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin 2 mg in 1 mL Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO) Hypromelloses 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Boric Acid (UNII: R57ZHV85D4) Calcium Chloride (UNII: M4I0D6VV5M) Glycine (UNII: TE7660XO1C) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Magnesium Chloride (UNII: 02F3473H9O) Polidronium Chloride (UNII: 6716Z5YR3G) Polysorbate 80 (UNII: 6OZP39ZG8H) Potassium Chloride (UNII: 660YQ98I10) Water (UNII: 059QF0KO0R) Sodium Chloride (UNII: 451W47IQ8X) Zinc Chloride (UNII: 86Q357L16B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-0426-36 1 in 1 CARTON 03/01/2016 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-0426-37 2 in 1 CARTON 03/01/2016 2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 03/01/2016 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-0426)