Rohto

Manufacturer: The Mentholatum Company | Rohto-Mentholatum (Vietnam) Co. Ltd.
Effective date: 2024-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 00:44:13

Label at a glance#

ProductRohto Cool

Active ingredientNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80

Label structure8 sections

Indications and uses

relieves redness of the eye due to minor eye irritations temporarily relieves burning and irritation due to dryness of the eye

Dosage and administration

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)

Contacts and useful links#

PhoneLabel contact1-877-636-2677

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Naphazoline hydrochloride 0.012%

Polysorbate 80 0.2%

Purpose

OTC - PURPOSE SECTION

Naphazoline hydrochloride - Redness reliever

Polysorbate 80 - Lubricant

Uses

INDICATIONS & USAGE SECTION

relieves redness of the eye due to minor eye irritations
temporarily relieves burning and irritation due to dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

WARNINGS AND PRECAUTIONS SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, purified water, sodium borate

Questions?

OTC - QUESTIONS SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1098362	naphazoline HCl 0.012 % / polysorbate 80 0.2 % Ophthalmic Solution	PSN	15
1098362	naphazoline hydrochloride 0.12 MG/ML / polysorbate 80 2 MG/ML Ophthalmic Solution	SCD	15
1098362	naphazoline hydrochloride 0.012 % / polysorbate 80 0.2 % Ophthalmic Solution	SY	15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e18001c8-33ae-5f66-9cdc-a39724bd4573	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10742-8142-1	2023-02-08	C162847	48780-1	f386c64a-3d8e-0266-e053-dadaa90a7c1a	Drug Facts
10742-8142-1	2023-01-30	C162847	48780-1	f386c64a-3d8e-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10742-8142-1	RohtoCool	1 in 1 CARTON	LIQUID	1		15
10742-8142-1	RohtoCool	13 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	13		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10742-8142	ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]	15	Legacy NDC, 2 package rows	20241219_69166dec-fb86-4c76-9efe-88c3bb12a8f0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAPHAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	MZ1131787D	6
POLYSORBATE 80	ACTIVE INGREDIENT	6OZP39ZG8H	6
NAPHAZOLINE	ACTIVE MOIETY	H231GF11BV	6
POLYSORBATE 80	ACTIVE MOIETY	6OZP39ZG8H	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	6
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	6
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	6
CHLOROBUTANOL	INACTIVE INGREDIENT	HM4YQM8WRC	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	6
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	6
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Rohto Cool
Naphazoline hydrochloride, Polysorbate 80
ALCOHOL
BENZALKONIUM CHLORIDE
BORIC ACID
CHLOROBUTANOL
EDETATE DISODIUM
MENTHOL, UNSPECIFIED FORM
WATER
SODIUM BORATE
NAPHAZOLINE HYDROCHLORIDE
NAPHAZOLINE
POLYSORBATE 80

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10742-8142	10742-8142-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
CHLOROBUTANOL	HM4YQM8WRC	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
NAPHAZOLINE HYDROCHLORIDE	MZ1131787D	ACTIB
POLYSORBATE 80	6OZP39ZG8H	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 223 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	INJECTION / SUBCUTANEOUS		60 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	LIQUID / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	SUSPENSION / INTRAMUSCULAR	3.5 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / OPHTHALMIC	2 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	JELLY / VAGINAL	1 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	TABLET / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	DROPS / NASAL	500 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	MOUTHWASH / BUCCAL	7.36 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	DROPS / OPHTHALMIC	1 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	SOLUTION / RESPIRATORY (INHALATION)	0.5 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	EMULSION / OPHTHALMIC	0.11 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
597bb11b-3a0b-54a7-e063-6294a90a694f			69166dec-fb86-4c76-9efe-88c3bb12a8f0	2026-08-20	Warnings	Exact identifier spl set id: 69166dec-fb86-4c76-9efe-88c3bb12a8f0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.