ROHTO COOL- naphazoline hydrochloride, polysorbate 80 liquid

Rohto by

Drug Labeling and Warnings

Rohto by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company, Rohto-Mentholatum (Vietnam) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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 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?

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

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ROHTO  COOL
naphazoline hydrochloride, polysorbate 80 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8142
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	1 mg  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8142-1	1 in 1 CARTON	08/21/2001
1		13 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	08/21/2001

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
Rohto-Mentholatum (Vietnam) Co. Ltd.		555347535	MANUFACTURE(10742-8142)