ROHTO COOL- naphazoline hydrochloride and polysorbate 80 liquid 
Rohto Pharmaceutical Co Ltd

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.

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Drug Facts

Active ingredients

Naphazoline hydrochloride 0.012%

Polysorbate 80 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever

Polysorbate - Lubricant

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

Ask a doctor before use if you have narrow angle glaucoma

When using this product

do not touch tip of container to any surface to avoid contamination
replace cap after each use
do not use if solution changes color or becomes cloudy
overuse may cause more eye redness
pupils may become enlarged temporarily
remove contact lenses before using

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eyes 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.

Directions

put 1 or 2 drops in the affected eye(s) up to 4 times daily
tightly snap on cap to seal

Other information

do not store above 25°C (77°F)

Inactive ingredients

alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

Questions?

Toll free 1-877-636-2677 MON - FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

Rohto Cool
ROHTO COOL 
naphazoline hydrochloride, polysorbate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66613-8142
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE0.12 mg  in 1 mL
POLYSORBATE 80 (POLYSORBATE 80) POLYSORBATE 802 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
BENZALKONIUM CHLORIDE 
BORIC ACID 
CHLOROBUTANOL 
EDETATE DISODIUM 
MENTHOL 
WATER 
SODIUM BORATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66613-8142-11 in 1 CARTON08/21/2001
113 mL in 1 BOTTLE; Combination Product Type = C112160
2NDC:66613-8142-27 mL in 1 BOTTLE; Combination Product Type = C11216010/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/21/2001
Labeler - Rohto Pharmaceutical Co Ltd (690573662)

Revised: 11/2014
Document Id: 0637c366-969c-4eec-810e-a8914a09bf47
Set id: ba443a89-2e47-45c9-bd48-e1e52b5ddcb0
Version: 3
Effective Time: 20141104
 
Rohto Pharmaceutical Co Ltd