EQUALINE LUBRICANT EYE DROPS- polyethylene glycol 400, propylene glycol solution/ drops

Equaline Lubricant Eye Drops by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Polyethylene glycol 0.4%

Propylene glycol 0.3%

Purposes

Lubricant

Lubricant

Use

• for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if you experience any of the following:

• eye pain
• changes in vision occur
• continued redness or irritation of the eye
• condition worsens or persists for more than 72 hours

Keep out of reach of children.

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

Directions

put 1 or 2 drops in the affected eye(s) as needed

Other information

Store at 15°-25°C (59°-77°F)

Inactive ingredients

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium hydroxide

Questions or comments?

Call 1-855-423-2630

Equaline Lubricant Eye Drops 10mL

INGREDIENTS AND APPEARANCE

EQUALINE LUBRICANT EYE DROPS 
polyethylene glycol 400, propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83455-208
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83455-208-01	1 in 1 BOX	06/20/2023
1		10 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
Unimed Pharmaceuticals, Inc.		688016567	manufacture(83455-208) , pack(83455-208) , label(83455-208)