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 Strategic Sourcing Services LLC, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Tetrahydrozoline HCl 0.05%

PURPOSE

Purpose

Tetrahydrozoline HCl - Redness reliever

INDICATIONS & USAGE

Uses

• 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 as 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 right away.

DOSAGE & ADMINISTRATION

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

OTHER SAFETY INFORMATION

Other information

Store at 15º - 30ºC (59º - 86°F)

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

Carton EyeDropsReg.jpg

INGREDIENTS AND APPEARANCE

EYE DROPS REGULAR 
tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0102
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
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62011-0102-1	1 in 1 CARTON	03/01/2012
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	03/01/2012

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(62011-0102) , pack(62011-0102) , label(62011-0102)