VISINE RED EYE TOTAL COMFORT MULTI-SYMPTOM- tetrahydrozoline hydrochloride, polyethylene glycol 400, and zinc sulfate, unspecified form solution/ drops

Visine Red Eye Total Comfort Multi-Symptom by

Drug Labeling and Warnings

Visine Red Eye Total Comfort Multi-Symptom by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. 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
Zinc sulfate 0.25%	Astringent

Uses

• for the temporary relief of discomfort and redness of the eye due to minor eye irritations
• relieves dryness of the eye
• for the 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

• some users may experience a brief tingling sensation
• 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

benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

UP TO 10 HRS COMFORT

VISINE®

RED EYE
TOTAL COMFORT
MULTI-SYMPTOM
ASTRINGENT /LUBRICANT
REDNESS RELIEVER EYE DROPS
ALL-IN ONE RELIEF
From Red, Burning, Watery,
Itchy, Dry, Gritty, Irritated Eyes
Protects Against
Further Irritation
STERILE
1/2 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

VISINE RED EYE TOTAL COMFORT MULTI-SYMPTOM 
tetrahydrozoline hydrochloride, polyethylene glycol 400, and zinc sulfate, unspecified form solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0360
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
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE, UNSPECIFIED FORM	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0360-1	1 in 1 CARTON	04/27/2020
1		15 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 FINAL	part349	04/27/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)