SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT- dextran, polyethylene glycol, povidone, tetrahydrozoline liquid

Sunmark Eye Drops Advanced Moisturizer/Lubricant by

Drug Labeling and Warnings

Sunmark Eye Drops Advanced Moisturizer/Lubricant by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dextran 70 0.1%
povidone 1%
Polyethylene glycol 400 1%
Tetrahydrozoline HCL 0.05%

Purpose

Eye Lubricant

Redness reliever

Uses

• relieves redness of the eye due to minor eye irritations
• as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glucoma

When using this product

• pupils may become enlarged temporarily
• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• if solution changes color or become cloudy, do not use
• overuse may produce increased redness of the eye
• 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 healthcare 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) up to four times daily.

Other information

Store at 15 o- 30 oC (59 o- 86 oF)

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT 
dextran, polyethylene glycol, povidone, tetrahydrozoline liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-697
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.1 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	1 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BORIC ACID (UNII: R57ZHV85D4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-697-29	1 in 1 CARTON	03/01/2007
1		15 mL in 1 BOTTLE, PLASTIC; 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	03/01/2007

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(49348-697) , pack(49348-697) , label(49348-697)