Label: ARTIFICIAL TEARS- glycerin, hypromellose, polyethylene glycol 400 liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-865-05 - Packager: American Sales Company
- 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 October 28, 2019
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
Stop use and ask a doctor if you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours
- Directions
- Other information
- Inactive ingredients
- Package principal display panel
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INGREDIENTS AND APPEARANCE
ARTIFICIAL TEARS
glycerin, hypromellose, polyethylene glycol 400 liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-865 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 10 mg in 1 mL HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LACTATE (UNII: TU7HW0W0QT) GLYCINE (UNII: TE7660XO1C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-865-05 1 in 1 BOX 09/10/2010 1 15 mL in 1 BOTTLE; 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 09/06/2010 Labeler - American Sales Company (809183973)