EQUALINE REDNESS RELIEF LUBRICANT EYE DROPS- glycerin, naphazoline hydrochloride solution/ drops

Equaline Redness Relief Lubricant Eye Drops by

Drug Labeling and Warnings

Equaline Redness Relief Lubricant 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

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purpose

Lubricant and redness reliever

Uses

• relieves redness of the eye due to minor eye irritations
• for use as a protectant against further irritation or to relieve dryness of the eye
• temporarily relieves burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use this product if

• solution changes color or becomes cloudy

Ask a doctor before use

if you have narrow angle glaucoma

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after using
• overuse may cause more redness of the eye
• pupils may become enlarged temporarily

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens
• symptoms last for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

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

Other information

store at room temperature

Inactive ingredients

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

Equaline Redness Relief Lubricant Eye Drops 15mL

INGREDIENTS AND APPEARANCE

EQUALINE REDNESS RELIEF LUBRICANT EYE DROPS 
glycerin, naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83455-213
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.012 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83455-213-01	1 in 1 BOX	01/01/2024
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	01/01/2024

Labeler - United Natural Foods, Inc (943556183)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(83455-213) , pack(83455-213) , label(83455-213)