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

Equaline Multi-Symptom Eye Drops by

Drug Labeling and Warnings

Equaline Multi-Symptom Eye Drops by is a Otc medication manufactured, distributed, or labeled by United Natural Foods, Inc., KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	06/20/2023

Labeler - United Natural Foods, Inc. (943556183)

Registrant - KC Pharmaceuticals, Inc. (174450460)

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