REXALL STERILE ARTIFICIAL TEARS EYE DROPS- glycerin solution

Rexall Sterile Artificial Tears Eye Drops by

Drug Labeling and Warnings

Rexall Sterile Artificial Tears Eye Drops by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                              Purpose

Glycerin 0.2%..................................................................................Lubricant

Hypromellose 0.2%..........................................................................Lubricant

Polyethylene glycol 400 1%..............................................................Lubricant

PURPOSE

Uses

• for the temporary relief of burning and irritation due to dryness of the eye
• for protection against further irritation
  

WARNINGS

Warnings for external use only

WHEN USING

When using this product

• remove contact lenses before use
• do not use if this solution changes color or becomes cloudy
• do not touch tip of container or any surface to avoid contamination
• replace cap after each use
  

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens or last more than 72 hours
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Directions

• put 1 to 2 drops in the affected eye(s) as needed.
• children under 6 years of age: ask a doctor.
  

STORAGE AND HANDLING

Other information

• some users may experience a brief tingling sensation
• store at 15° to 25°C (59°-77°F)
  

INACTIVE INGREDIENT

Inactive ingredients benzalkonium chloride, boric acid, dextrose, glycine, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate.

DOSAGE & ADMINISTRATION

Packaged For:

Dolgencorp, LLC

100 Mission Ridge

Goodlettsville, TN 37072 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REXALL STERILE ARTIFICIAL TEARS EYE DROPS 
glycerin solution

Product 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)