VISINE RED EYE HYDRATING COMFORT EYE DROPS- tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ drops

Visine Red Eye Hydrating Comfort by

Drug Labeling and Warnings

Visine Red Eye Hydrating Comfort by is a Otc medication manufactured, distributed, or labeled by Morning Star OTC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Polyethylene glycol 400 1%	Lubricant
Tetrahydrozoline HCl 0.05%	Redness reliever

Uses

• for the relief of redness of the eye due to minor eye irritations
• for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
• for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only.

Ask a doctor before use if you havenarrow angle glaucoma.

When using this product

• pupils may become enlarged temporarily
• overuse may cause more eye redness
• remove contact lenses before using
• do not use if this solution changes color or becomes cloudy
• 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 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 right away.

Directions

• adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
• children under 6 years of age: consult a doctor
• children under 2 years of age: do not use

Other information

Store at 20° to 25°C (68° to 77°F)

Inactive ingredients

ascorbic acid, boric acid, dextrose, glycerin, glycine, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

Questions?

call toll-free 888-734-7648or 215-273-8755(collect)

SPL UNCLASSIFIED SECTION

Repackaged by:
Morning Star OTC
145 S. Anderson St, Los Angeles,
CA 90033

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VISINE RED EYE HYDRATING COMFORT   EYE DROPS
tetrahydrozoline hydrochloride and polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53209-6001(NDC:69968-0356)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLIXETONIUM CHLORIDE (UNII: RNW5AM67C0)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53209-6001-1	1 in 1 BLISTER PACK	06/16/2025
1		8 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	04/27/2020

Labeler - Morning Star OTC (078589357)

Registrant - Morning Star OTC (078589357)

Establishment
Name	Address	ID/FEI	Business Operations
Morning Star OTC		078589357	repack(53209-6001)