ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid
Rohto-Mentholatum (Vietnam) 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 ingredient

Naphazoline hydrochloride 0.012%

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

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

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)

Package/Label Principal Display Panel

ROHTO COOL
naphazoline hydrochloride, polysorbate 80 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75977-8142
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	.12 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) (POLYSORBATE 80 - UNII:6OZP39ZG8H)	POLYSORBATE 80	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

#	Item Code	Package Description
Packaging
1	NDC:75977-8142-1	1 in 1 CARTON
1		13 mL in 1 BOTTLE
2	NDC:75977-8142-2	7 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	02/01/2012

Labeler - Rohto-Mentholatum (Vietnam) Co. Ltd. (555270813)

Registrant - The Mentholatum Company (002105757)

Name	Address	ID/FEI	Business Operations
Establishment
Rohto-Mentholatum (Vietnam) Co. Ltd.		555270813	MANUFACTURE(75977-8142)

Revised: 7/2013

Document Id: 55115d24-691c-426f-95d3-f6aa0d1c217c

Set id: 903ed845-4826-48ca-8436-39ddd20cbd47

Version: 3

Effective Time: 20130709

Rohto-Mentholatum (Vietnam) Co. Ltd.