ROHTO COOL MAX- naphazoline hydrochloride, 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 0.03%

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
ROHTO  COOL MAX
naphazoline hydrochloride, polysorbate 80 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66613-8159
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.3 mg  in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H) POLYSORBATE 802 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 1 mg  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
CHLOROBUTANOL (UNII: HM4YQM8WRC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL (UNII: L7T10EIP3A)  
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66613-8159-11 in 1 CARTON05/05/2014
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)

Revised: 5/2014
Document Id: b3c35906-151e-4a2f-b27d-2e90627d6273
Set id: 11ecd80a-19e5-49fb-bc20-81de134c6500
Version: 2
Effective Time: 20140505
 
Rohto Pharmaceutical Co. Ltd.