Label: GENTEAL TEARS GEL DROPS- polyethylene glycol 400 and propylene glycol gel
- NDC Code(s): 0065-8067-01
- 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 21, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- Warnings
- Do not use
- When using this product
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
Severe Day + Night
DRY EYE SYMPTOM RELIEF GEL DROPS
GenTeaL® Tears
LUBRICANT EYE DROPS
GEL DROPS
Strength of a Gel,
Convenience of a drop
STERILE
Alcon 8ml (0.3 FL OZ)
TAMPER EVIDENT:
For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.
GENTEAL® TEARS Gel Drops contains two lubricants to deliver the relief of a gel with the comfort and convenience of a drop.
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INGREDIENTS AND APPEARANCE
GENTEAL TEARS GEL DROPS
polyethylene glycol 400 and propylene glycol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-8067 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 400 4 mg in 1 mL Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Aminomethylpropanol (UNII: LU49E6626Q) Boric Acid (UNII: R57ZHV85D4) Edetate Disodium (UNII: 7FLD91C86K) Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC) Polidronium Chloride (UNII: 6716Z5YR3G) Potassium Chloride (UNII: 660YQ98I10) Sodium Chloride (UNII: 451W47IQ8X) Sorbitol (UNII: 506T60A25R) Water (UNII: 059QF0KO0R) Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-8067-01 8 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 02/01/2021 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-8067)