Eye Drops SY by KC Pharmaceuticals, Inc. / KC Pharmaceuticals, inc.

Eye Drops SY by

Drug Labeling and Warnings

Eye Drops SY by is a Otc medication manufactured, distributed, or labeled by KC Pharmaceuticals, Inc., KC Pharmaceuticals, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYE DROPS SY- polyethylene glycol 400, propylene glycol 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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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

Directions

Instill 1 or 2 drops in the affected eye(s) as needed

Children under 6 years of age: ask a doctor

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 room temperature

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

EYE DROPS SY 
polyethylene glycol 400, propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-028
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	4 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-028-01	1 in 1 CARTON	03/17/2010	03/17/2010
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	03/17/2010	03/17/2010

Labeler - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(55651-028) , pack(55651-028) , label(55651-028)

Revised: 11/2019

Document Id: 985e6ff2-d399-e438-e053-2a95a90af25a

34390-5

Set id: 00871efc-519f-4af8-9a34-a56cd8c7bdc9

Version: 3

Effective Time: 20191127