QC ULTRA LUBRICANT EYE- polyethylene glycol 400, and propylene glycol solution/ drops

QC Ultra Lubricant Eye by

Drug Labeling and Warnings

QC Ultra Lubricant 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
Polyethylene glycol 400 0.4%.............................Lubricant
Propylene glycol 0.3%.........................................Lubricant

PURPOSE

Use

• For the temporary relief of burning and irritation due to dryness of the eye

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

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

WHEN USING

When using this product

• do not touch tip of container to any surface to avoid contamination
• do not reuse
• once opened, discard

STOP USE

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

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.

STORAGE AND HANDLING

Other information

• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

aminomethylpropanol, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, sodium hydroxide, sorbitol, water for injection

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

QC ULTRA LUBRICANT EYE 
polyethylene glycol 400, and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-634
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-634-04	25 in 1 CARTON	09/30/2016
1		0.4 mL in 1 VIAL, SINGLE-USE; 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	09/30/2016

Labeler - Chain Drug Marketing Association Inc (011920774)