Drug Facts

SYSFOL EYE DROPS- polyethylene glycol 400, propylene glycol liquid
Unimed Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Polyethylene Glycol 400, Propylene Glycol

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium, hydroxide

for use as a protectant against further irritation or to relieve dryness of the eye

keep out of reach of the children

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

For external use only
When using this product
■ do not touch tip of container to any surface to avoid contamination
■ replace cap after each use

■ avoid direct sunlight

external use only

label

SYSFOL EYE DROPS
polyethylene glycol 400, propylene glycol liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73669-013-02	30 in 1 BOX	04/20/2023
1	NDC:73669-013-01	0.4 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/20/2023

Labeler - Unimed Pharmaceuticals, Inc. (689852052)

Registrant - Unimed Pharmaceuticals, Inc. (689852052)

Name	Address	ID/FEI	Business Operations
Establishment
Unimed Pharmaceuticals, Inc.		689852052	label(73669-013) , manufacture(73669-013) , pack(73669-013)