Active ingredients

Glycerin ................... 0.2%

Hypromellose ........... 0.2%

Polyethylene glycol 400 ......1%

Purposes

Glycerin.......................Lubricant

Hypromellose..............Lubricant

Polyethylene glycol 400.........Lubricant

Uses

for protection against further irritation
for temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.

Stop use and ask a doctor if you experience

eye pain
changes in vision
continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

instill 1 to 2 drops in the affected eye(s) as needed
children under 6 years of age: ask a doctor

Other information

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

carton

TOPCARE HEALTH DRY EYE RELIEF EYE DROPS
glycerin, hypromellose, polyethylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-845
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	0.2 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-845-01	1 in 1 CARTON	02/06/2020
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 Drug	M018	02/06/2020

Labeler - Topco Associates LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
K.C. Pharmaceuticals, Inc.		174450460	pack(36800-845) , label(36800-845) , manufacture(36800-845)

Topcare Health Dry Eye (PLD)