Label: REXALL STERILE ARTIFICIAL TEARS EYE DROPS- glycerin solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 55910-522-15 - Packager: Dolgencorp 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 30, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active ingredients Purpose
Glycerin 0.2%..................................................................................Lubricant
Hypromellose 0.2%..........................................................................Lubricant
Polyethylene glycol 400 1%..............................................................Lubricant
- PURPOSE
- WARNINGS
- 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
REXALL STERILE ARTIFICIAL TEARS EYE DROPS
glycerin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-522 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.002 mg in 1 mg HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES 0.002 mg in 1 mg POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 0.01 mg in 1 mg Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) DEXTROSE (UNII: IY9XDZ35W2) GLYCINE (UNII: TE7660XO1C) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-522-15 1 in 1 CARTON 1 15 mg in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 06/30/2013 Labeler - Dolgencorp Inc (068331990)