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Rohto Cool Max by Rohto Pharmaceutical Co. Ltd.

Dosage form: liquid
Ingredients: NAPHAZOLINE HYDROCHLORIDE .3mg in 1mL, POLYSORBATE 80 2mg in 1mL
Labeler: Rohto Pharmaceutical Co. Ltd.
NDC Code: 66613-8159

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

Naphazoline hydrochloride 0.03%

Polysorbate 80 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever

Polysorbate 80 - Lubricant

Uses
relieves redness of the eye due to minor eye irritations
temporarily relieves burning and irritation due to dryness of the eye
for protection against further irritation

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

When using this product
do not touch top 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, potassium aspartate, 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 MAX
naphazoline hydrochloride, polysorbate 80 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66613-8159
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE.3 mg  in 1 mL
POLYSORBATE 80 (POLYSORBATE 80) POLYSORBATE 802 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL1 mg  in 1 mL
BENZALKONIUM CHLORIDE 
BORIC ACID 
CHLOROBUTANOL 
EDETATE DISODIUM 
MENTHOL 
POTASSIUM ASPARTATE 
WATER 
SODIUM BORATE 
Packaging
#Item CodePackage Description
1NDC:66613-8159-11 BOTTLE, WITH APPLICATOR in 1 CARTON
113 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/05/2014
Labeler - Rohto Pharmaceutical Co. Ltd. (690573662)

 
Rohto Pharmaceutical Co. Ltd.

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Medically reviewed on May 7, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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