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 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

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 have narrow 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 888-734-7648 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

VISINE®
RED EYE
HYDRATING
COMFORT
LUBRICANT/REDNESS RELIEVER EYE DROPS

WORKS IN 30 SECONDS
Redness + Irritation Relief

Lubricates +
Refreshes
STERILE
1/2 FL OZ (15mL)

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: 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
Ascorbic Acid (UNII: PQ6CK8PD0R)
Boric Acid (UNII: R57ZHV85D4)
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: 69968-0356-2	1 in 1 CARTON	04/27/2020
1		15 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2	NDC: 69968-0356-1	700 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	04/27/2020
2		8 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
3	NDC: 69968-0356-3	1 in 1 CARTON	04/27/2020
3		8 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
4	NDC: 69968-0356-4	1 in 1 BLISTER PACK	04/27/2020
4		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 FINAL	part349	04/27/2020

Labeler - Johnson & Johnson Consumer Inc. (002347102)