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

TopCare Ultra Lubricant by

Drug Labeling and Warnings

TopCare Ultra Lubricant by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. 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

Uses

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

WARNINGS

Warnings

For external use only.

Do not use

• if this product changes color 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
• replace cap after each use

STOP USE

Stop use and ask a doctor if

• you fell 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

• Shake well before using.
• 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

boric acid, calcium chloride, chlorhexidine gluconate (20%), hydrochloric acid, hypromellose 2910, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

DOSAGE & ADMINISTRATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO UNX416

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE ULTRA LUBRICANT 
polyethylene glycol 400, and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-680
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
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
HYDROCHLORIC ACID (UNII: QTT17582CB)
HYPROMELLOSE 2910 (15000 MPA.S) (UNII: 288VBX44JC)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ZINC CHLORIDE (UNII: 86Q357L16B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-680-15	1 in 1 BOX	09/30/2016
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 final	part349	09/30/2016

Labeler - Topco Associates LLC (006935977)