Active ingredient

Tetrahydrozoline HCL 0.05%

Purpose

Redness reliever

For external use only

narrow angle glaucoma

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

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

ask a health professional before use

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

store at 15-30°C (59°-86°F)

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

EQUALINE STERILE EYE DROPS
tetrahydrozoline hcl solution/ drops

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
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:83455-210-01	1 in 1 BOX	01/01/2024
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 Drug	M018	01/01/2024

Labeler - United Natural Foods, Inc. (943556183)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	pack(83455-210) , manufacture(83455-210) , label(83455-210)