OPTIC SPLASH- naphazoline hydrochloride, glycerin solution/ drops 
Sato Pharmaceutical, Co., Ltd.

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Optic Splash

Active ingredients
Glycerin 0.2%
Naphazoline hydrochloride 0.02%

Purpose
Glycerin     Lubricant
Naphazoline hydrochloride     Redness reliever

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

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.

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

Other information
■ store tightly closed, protected from light.

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

opticsplashcart.jpg carton

OPTIC SPLASH 
naphazoline hydrochloride, glycerin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-501
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE20 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID (UNII: R57ZHV85D4)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-501-011 in 1 CARTON01/22/2008
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01801/22/2008
Labeler - Sato Pharmaceutical, Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical, Co. Ltd.715699133manufacture(49873-501) , label(49873-501) , pack(49873-501)

Revised: 12/2023
Document Id: 0bb98362-089f-f332-e063-6394a90ad51f
Set id: e3d60c20-7cbc-4728-8e42-441b64608b88
Version: 4
Effective Time: 20231204
 
Sato Pharmaceutical, Co., Ltd.