EYE DROPS LUBRICATING TEARS- hypromellose, glycerin, polyethylene glycol 400 solution/ drops
KC Pharmaceuticals, Inc.

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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Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Glycerin - Lubricant

Hypromellose - Lubricant

Polyethylene glycol 400 - Lubricant

Keep out of reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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

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

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

Directions

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

Inactive Ingredients

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

Other information

Tamper Evident. Do not use this product if imprinted neckband on bottle is broken or missing.
Retain this carton for future reference
Store at 15o - 30oC (59o - 86oF)

If pregnant or breast feeding,

ask a health professional before use

EDLT

EYE DROPS LUBRICATING TEARS
hypromellose, glycerin, polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55651-026
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg in 1 mL
HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO)	HYPROMELLOSES	2 mg in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55651-026-01	1 in 1 CARTON	05/12/2008	05/12/2008
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	05/12/2008	05/12/2008

Labeler - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(55651-026) , pack(55651-026) , label(55651-026)

Revised: 11/2019

Document Id: 984979a9-f727-b741-e053-2995a90a93a3

Set id: 5ac223b9-6384-4556-ad1a-c2d27f96e4df

Version: 3

Effective Time: 20191126

KC Pharmaceuticals, Inc.