QUALITY CHOICE LUBRICANT TEARS EYE- glycerin, hypromellose, polyethylene glycol 400 solution/ drops

QUALITY CHOICE LUBRICANT TEARS EYE by

Drug Labeling and Warnings

QUALITY CHOICE LUBRICANT TEARS EYE by is a Otc medication manufactured, distributed, or labeled by CHAIN DRUG MARKETING ASSOCIATION 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.

DO NOT USE

Do not use:

• if this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product
  

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 to 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 lasts 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

• Instill 1 or 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 15o to 25oC (59o to 77oF)
  

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

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE LUBRICANT TEARS EYE  
glycerin, hypromellose, polyethylene glycol 400 solution/ drops

Product 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)