VISINE ORIGINAL REDNESS RELIEF- tetrahydrozoline hydrochloride solution/ drops

Visine Original by

Drug Labeling and Warnings

Visine Original 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 ingredients

Tetrahydrozoline HCl 0.05%

Purpose

Redness reliever

Use

• for the relief of redness of the eye due to minor eye irritations

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

• put 1 to 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years of age: ask 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 chloride

Questions?

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

SPL UNCLASSIFIED SECTION

Dist: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc., Skillman, NJ 08558 USA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Sterile
Visine®

ORIGINAL
Redness Relief
TETRAHYDROZOLINE HCl
REDNESS RELIEVER EYE DROPS

Gets the
Red Out®

Fast-acting
formula

1/2 FL OZ (15mL)

INGREDIENTS AND APPEARANCE

VISINE ORIGINAL   REDNESS RELIEF
tetrahydrozoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-203
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

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Water (UNII: 059QF0KO0R)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-203-02	1 in 1 CARTON	10/01/2009
1		15 mL in 1 BOTTLE, DROPPER; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
2	NDC: 42002-203-35	1 in 1 CARTON	10/01/2009
2		19 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	10/01/2009

Labeler - Johnson & Johnson Consumer Inc. (002347102)