Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Purpose

Lubricant

Lubricant
Lubricant

Uses

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

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. Keep container tightly closed.
remove contact lens before 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 accidentally swallowed get medical help or contact a Poison Control Center immediately.

Directions

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

Other information

Store at 15 °-30°C (59°-86°F)

Inactive ingredients

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

Core Values Eye Drops Dry Eye Relief

box

CORE VALUES EYE DROPS DRY EYE RELIEF
glycerin, hypromellose, polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63940-035
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63940-035-01	1 in 1 BOX	03/30/2023
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	03/30/2023

Labeler - Liberty Procurement Co. Inc. (804085293)

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

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(63940-035) , pack(63940-035) , label(63940-035)

Core Values Eye Drops Dry Eye Relief 15 mL (PLD)

​Active ingredients

​Purpose

​Uses

​Warnings