Eye Drops Advanced Relief (Tetrahydrozoline Hydrochloride, Polyethylene Glycol 400, Dextran 70, Povidone) Solution/ Drops [Kc Pharmaceuticals, Inc.] -

EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]
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NDC	55651-025-01
Set ID	ab906fd8-265c-4359-a920-d626366e245c
Category	HUMAN OTC DRUG LABEL
Packager	KC Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number	PART349

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ACTIVE INGREDIENT

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%
PURPOSE

Purposes

Dextran 70..................Lubricant

Polyethylene glycol 400....Lubricant

Povidone...........................Lubricant

Tetrahydrozoline HCl........Redness reliever
INDICATIONS & USAGE
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

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

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 becomes 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 health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily
OTHER SAFETY INFORMATION

Other information

store at 15°-30°C (59°-86°F)
INACTIVE INGREDIENT

Inactive ingredients

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

sodium chloride
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EYE DROPS ADVANCED RELIEF
tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55651-025
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg in 1 mL
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	10 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55651-025-01	1 in 1 CARTON	12/09/2003
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	12/09/2003

Labeler - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(55651-025) , pack(55651-025) , label(55651-025)

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Medic

EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]

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