Optic Splash

Dosage form: solution/ drops
Ingredients: NAPHAZOLINE HYDROCHLORIDE 20mg in 100mL, GLYCERIN 200mg in 100mL
Labeler: Sato Pharmaceutical, Co., Ltd.
NDC Code: 49873-501

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

Ask 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 our 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

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OPTIC SPLASH 
naphazoline hydrochloride, glycerin solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-501
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE20 mg  in 100 mL
GLYCERIN (GLYCERIN) GLYCERIN200 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
CAMPHOR (SYNTHETIC) 
LEVOMENTHOL 
POLYSORBATE 80 
POTASSIUM CHLORIDE 
SODIUM BORATE 
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:49873-501-011 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/22/2008
Labeler - Sato Pharmaceutical, Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical, Co. Ltd.715699133manufacture, label, pack

Revised: 02/2012
 
Sato Pharmaceutical, Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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