Drug Facts

Active ingredients	Purpose
Naphazoline HCl 0.025%	Redness reliever
Pheniramine maleate 0.3%	Antihistamine

Uses

Temporarily relieves itchy, red eyes due to:

pollen
ragweed
grass
animal hair and dander

Warnings

For external use only

Do not use if you are sensitive to any ingredient in this product.

Ask a doctor before use if you have

heart disease
high blood pressure
narrow angle glaucoma
trouble urinating

When using this product

pupils may become enlarged temporarily causing light sensitivity
do not touch tip of container to any surface to avoid contamination
replace cap after each use
remove contact lenses before using
do not use if this solution changes color or becomes cloudy
overuse may cause more eye redness
some users may experience a brief tingling sensation

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

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

Other information

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium hydroxide and/or hydrochloric acid

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 ®

NAPHAZOLINE HCl 0.025%

AND PHENIRAMINE MALEATE 0.3%

OPHTHALMIC SOLUTION

ANTIHISTAMINE AND REDNESS RELIEVER

ALLERGY EYE RELIEF

MULTI-ACTION

ORIGINAL

PRESCRIPTION STRENGTH

Clinically Proven to

Relieve Red,

Itchy Eyes

STERILE

EYE DROPS

1/2 FL OZ (15mL)

0367

VISINE ALLERGY EYE RELIEF MULTI-ACTION
naphazoline hydrochloride and pheniramine maleate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69968-0367
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.25 mg in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69968-0367-1	1 in 1 CARTON	05/06/2019
1		15 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2	NDC:69968-0367-2	2 in 1 CARTON	06/03/2019
2		15 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020485	05/06/2019

Labeler - Kenvue Brands LLC (118772437)

Visine® Allergy Eye Relief Multi-Action