Label: GENTEAL TEARS (MODERATE)- dextran 70, glycerin, hypromellose solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-5050-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0065-0426
- 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 April 15, 2021
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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:
- HOW SUPPLIED
- Questions?
- Dextran 70, Glycerin, Hypromellose
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INGREDIENTS AND APPEARANCE
GENTEAL TEARS (MODERATE)
dextran 70, glycerin, hypromellose solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5050(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:50090-5050-0 1 in 1 CARTON 05/15/2020 1 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 - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-5050)