TOPCARE HEALTH LUBRICANT EYE DROPS- polyethylene glycol 400, propylene glycol solution

Topcare Health Lubricant Eye Drops by

Drug Labeling and Warnings

Topcare Health Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Topco Assoc LLC, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

PURPOSE

Purpose

Polyethylene glycol 400.....Lubricant

Propylene glycol........Lubricant

INDICATIONS & USAGE

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

When using this product

• do not touch the tip of container to any surface to avoid contamination
• replace cap after each 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 or lasts more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed
• Children under 6 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

• RETAIN THIS CARTON FOR FUTURE REFERENCE
• Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE HEALTH LUBRICANT EYE DROPS 
polyethylene glycol 400, propylene glycol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-978
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-978-01	1 in 1 CARTON	02/07/2020
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	02/07/2020

Labeler - Topco Assoc LLC (006935977)

Registrant - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(36800-978) , pack(36800-978) , label(36800-978)