NDC | 63868-967-15 |
Set ID | ac9fb8ee-d0b9-43dc-900b-1362b56974cc |
Category | HUMAN OTC DRUG LABEL |
Packager | CHAIN DRUG MARKETING ASSOCIATION INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Glycerin 0.2%..................................................................................Lubricant
Hypromellose 0.2%..........................................................................Lubricant
Polyethylene glycol 400 1%..............................................................Lubricant
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE LUBRICANT TEARS EYE
glycerin, hypromellose, polyethylene glycol 400 solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-967 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2 mg in 1 mL HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES 2 mg in 1 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-967-15 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 09/30/2012 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)