QUALITY CHOICE LUBRICANT EYE DROPS RESTORATIVE PERFORMANCE- propylene glycol solution/ drops

Quality Choice Lubricant Eye Drops Restorative Performance by

Drug Labeling and Warnings

Quality Choice Lubricant Eye Drops Restorative Performance by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Assoc., Inc., KC Pharmaceuticals, Inc., Daewoo Pharmaceuticals, Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Propylene glycol 0.6%

Purpose

Lubricant

Use

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

Warnings

For external use only

Do not use

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

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if

• you experience 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.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well before using
• instill 1 or 2 drops in the affected eye(s) as needed

Other information

• store at room temperature

Inactive ingredients

benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, **hydrochloric acid, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride, **sodium hydroxide

**May contain these ingredients to adjust pH

Quality Choice Lubricant Eye Drops Restorative Performance 15mL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE LUBRICANT EYE DROPS RESTORATIVE PERFORMANCE 
propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-028
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
CASTOR OIL (UNII: D5340Y2I9G)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-028-15	1 in 1 BOX	12/12/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	12/12/2023

Labeler - Chain Drug Marketing Assoc., Inc. (011920774)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
Daewoo Pharmaceuticals, Co., Ltd.		689046329	manufacture(83324-028) , pack(83324-028) , label(83324-028)