SYSFOL EYE DROPS- polyethylene glycol 400, propylene glycol liquid

Sysfol Eye Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Polyethylene Glycol 400, Propylene Glycol

INACTIVE INGREDIENT

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

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SYSFOL EYE DROPS 
polyethylene glycol 400, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73669-013
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	0.4 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/20/2023

Labeler - Unimed Pharmaceuticals, Inc. (689852052)

Registrant - Unimed Pharmaceuticals, Inc. (689852052)

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