Label: QUALITY CHOICE LUBRICANT TEARS EYE- glycerin, hypromellose, polyethylene glycol 400 solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-967-15 - Packager: CHAIN DRUG MARKETING ASSOCIATION 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 September 30, 2012
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- Official Label (Printer Friendly)
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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
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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)