Eye Drops Ac (Tetrahydrozoline Hydrochloride, Zinc Sulfate) Solution/ Drops [Kc Pharmaceuticals, Inc.] -

EYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]
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ACTIVE INGREDIENT

Active ingredients

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%
PURPOSE

Purposes

Tetrahydrozoline HCl.....Redness reliever

Zinc sulfate...............Astringent
INDICATIONS & USAGE

Use

■ for temporary relief of discomfort and redness of the eye due to minor eye irritations
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 chloride, sodium citrate
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EYE DROPS AC
tetrahydrozoline hydrochloride, zinc sulfate solution/ drops

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	2.5 mg in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55651-024-01	1 in 1 CARTON	10/23/2003
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	10/23/2003

Labeler - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(55651-024) , pack(55651-024) , label(55651-024)

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