Drug Facts

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)

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)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	04/27/2020

Labeler - Johnson & Johnson Consumer Inc. (118772437)

VISINE ® Red Eye Hydrating Comfort