Your browser does not support JavaScript! ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE) LIQUID [ROHTO PHARMACEUTICAL CO LTD]
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RxNorm Names

ROHTO COOL (naphazoline hydrochloride, polysorbate) liquid
[Rohto Pharmaceutical Co Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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

Other information

•
do not store above 25°C (77°F)
•
tightly snap on cap to seal

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) consumeraffairs@mentholatum.com

Package/Label Principal Display Panel

Rohto Cool Redness Relief
ROHTO COOL 
naphazoline hydrochloride, polysorbate liquid
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:66613-8142-11 in 1 CARTON
113 mL in 1 BOTTLE
2NDC:66613-8142-27 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/21/2001
Labeler - Rohto Pharmaceutical Co Ltd (690573662)

Revised: 10/2012
Document Id: 1ecba72e-8644-4e87-9f42-16759e58e237
Set id: ba443a89-2e47-45c9-bd48-e1e52b5ddcb0
Version: 2
Effective Time: 20121010
 
Rohto Pharmaceutical Co Ltd

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