Active ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purposes

Lubricant

Redness reliever

Astringent

Uses

relieves dryness of the eye
for temporary relief of discomfort and redness of the eye due to minor eye irritations
for temporary relief of burning and irritation due to exposure to wind or sun
for protection against further 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
overuse may cause more eye redness
remove contact lenses before using
do not touch tip of container to any surface to avoid contamination
replace cap after using
do not use if this solution changes color or becomes cloudy

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts 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.

Directions

instill 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor

Other information

some users may experience a brief tingling sensation
store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

Call 1-855-423-2630

Equaline Multi-Symptom Eye Drops 15mL

EQUALINE MULTI-SYMPTOM EYE DROPS
polyethylene glycol 400, tetrahydrozoline hcl, zinc sulfate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83455-207
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	0.25 g in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83455-207-01	1 in 1 BOX	06/20/2023
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	06/20/2023

Labeler - United Natural Foods, Inc. (943556183)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	pack(83455-207) , manufacture(83455-207) , label(83455-207)

Equaline Multi-Symptom Eye Drops 15mL (PLD)