QUALITY CHOICE LUBRICANT EYE  - polyethylene glycol 400, propylene glycol solution/ drops 
CHAIN DRUG MARKETING ASSOCIATION INC

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.

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Drug Facts

Active ingredients                                                      Purpose

Polyethylene Glycol 400 (0.4%)..................................Lubricant

Propylene Glycol (0.3%).............................................Lubricant

Uses

For the relief of burning, irritation due to dryness of the eye.

Warnings

For external use only.

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hydroxypropyl Guar,

Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Zinc Chloride

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

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Made in Korea

image of carton label

QUALITY CHOICE LUBRICANT EYE  
polyethylene glycol 400, propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-968
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4004 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-968-151 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/30/2012
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 9/2012
Document Id: 0e4d5583-a1fa-4792-b8af-7a7846d8bec9
Set id: a829b0de-65dd-4e60-8090-64d0a064df32
Version: 2
Effective Time: 20120930
 
CHAIN DRUG MARKETING ASSOCIATION INC