OPTIC SPLASH- naphazoline hydrochloride, glycerin solution/ drops

Optic Splash by

Drug Labeling and Warnings

Optic Splash by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical, Co., Ltd., Sato Pharmaceutical, Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Glycerin 0.2%
Naphazoline hydrochloride 0.02%

PURPOSE

Purpose
Glycerin     Lubricant
Naphazoline hydrochloride     Redness reliever

INDICATIONS & USAGE

Uses
■ Relieves redness of the eye due to minor eye irritations.
■ Temporarily relieves burning and irritation due to dryness of the eye.

WARNINGS

Warnings
For external use only

Do not use

■ if solution changes color or becomes cloudy

A sk a doctor before use if you have

■ narrow angle glaucoma

When using this product

■ to avoid contamination, do not touch tip of container to any surface

■ replace cap after using

■ overuse of this product may produce increased redness of the eye

■ pupils may become enlarged temporarily

Stop use and ask a doctor if

■ you experience:

■ eye pain ■ changes in vision

■ continued redness or irritation of the eye

■ condition worsens or persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
Instill 1 to 2 drops in the affected eye(s) up to four times daily.

OTHER SAFETY INFORMATION

Other information
■ store tightly closed, protected from light.

INACTIVE INGREDIENT

Inactive ingredients
benzalkonium chloride, boric acid, camphor, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride

PRINCIPAL DISPLAY PANEL

opticsplashcart.jpg

INGREDIENTS AND APPEARANCE

OPTIC SPLASH 
naphazoline hydrochloride, glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-501
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	20 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	200 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
LEVOMENTHOL (UNII: BZ1R15MTK7)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-501-01	1 in 1 CARTON	01/22/2008
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/22/2008

Labeler - Sato Pharmaceutical, Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical, Co. Ltd.		715699133	manufacture(49873-501) , label(49873-501) , pack(49873-501)