Equaline Eye Drops A.C.15 mL (PLD)

Active ingredients

Tetrahydrozoline HCl....0.05%

Zinc sulfate.....0.25%

Purposes

Tetrahydrozoline HCl......Redness reliever

Zinc sulfate......Astringent

Use

for temporary relief of discomfort and redness of the eye due to minor eye irritation

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 (800-222-1222) right away.

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.

Other information

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

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

box

EQUALINE EYE DROPS A.C.
tetrahydrozoline hcl, zinc sulfate solution

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
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.25 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41163-540-01	1 in 1 CARTON	03/22/2023
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	03/22/2023

Labeler - United Natural Foods, Inc. (943556183)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
K.C. Pharmaceuticals, Inc.		174450460	manufacture(41163-540) , pack(41163-540) , label(41163-540)