EQUALINE ADVANCED RELIEF EYE DROPS- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ drops

Equaline Advanced Relief Eye Drops by

Drug Labeling and Warnings

Equaline Advanced Relief Eye Drops by is a Otc medication manufactured, distributed, or labeled by Supervalu, K.C. Pharmaceuticals, Inc., KC Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Purposes

Lubricant

Lubricant

Lubricant

Redness reliever

Uses

• relieves redness of the eye due to minor eye irritations
• as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Ask a doctor before us 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 (1-800-222-1222) right away.

Directions

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

Other information

Store at 15 °-30°C (59°-86°F)

Inactive ingredients

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

Equaline Advanced Relief Eye Drops

INGREDIENTS AND APPEARANCE

EQUALINE ADVANCED RELIEF EYE DROPS 
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-338
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	0.1 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-338-01	1 in 1 BOX	03/19/2023
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	03/19/2023

Labeler - United Natural Foods, Inc. (943556183)

Registrant - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc		174450460	manufacture(41163-338) , label(41163-338) , pack(41163-338)