EYE DROPS REGULAR- tetrahydrozoline hydrochloride solution/ drops

Eye Drops Regular by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Tetrahydrozoline HCl 0.05%

PURPOSE

Purpose

Tetrahydrozoline HCl.................Redness reliever

INDICATIONS & USAGE

Use

■ relieves 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 borate, sodium chloride

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EYE DROPS REGULAR 
tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-005
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-005-01	1 in 1 CARTON	08/28/2003
1		15 mL in 1 BOTTLE, DROPPER; 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	08/28/2003

Labeler - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(55651-005) , pack(55651-005) , label(55651-005)