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

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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TC Lub Eye Drop/PLD

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purpose

Polyethylene glycol 400.....Lubricant

Propylene glycol........Lubricant

Uses

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 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

Directions

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

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at room temperature

Inactive ingredients

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

carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	02/07/2020

Labeler - Topco Assoc LLC (006935977)

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

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

Revised: 2/2020

Document Id: 9e0593a2-c1b2-47e0-e053-2a95a90a6540

Set id: 9c6284f9-00bb-37b5-e053-2a95a90ae2ee

Version: 2

Effective Time: 20200207

Topco Assoc LLC