Rohto

Manufacturer: The Mentholatum Company | Rohto-Mentholatum (Vietnam) Co. Ltd.
Effective date: 2024-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:44:08

Label at a glance#

ProductRohto Cool Max

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 for protection against further irritation

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 0.03%

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
for protection against further irritation

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 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

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, potassium aspartate, purified water, sodium borate

Questions?

OTC - QUESTIONS SECTION

Toll free 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
1535485	naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic Solution	PSN	9
1535485	naphazoline hydrochloride 0.3 MG/ML / polysorbate 80 2 MG/ML Ophthalmic Solution	SCD	9
1535485	naphazoline HCl 0.03 % / polysorbate 80 0.2 % Ophthalmic Solution	SY	9

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
10742-8159-1	2023-02-08	C162847	48780-1	f386c649-acc3-0266-e053-dadaa90a7c1a	Drug Facts - Rohto Cool Max
10742-8159-1	2023-01-30	C162847	48780-1	f386c649-acc3-0266-e053-dadaa90a7c1a	Drug Facts - Rohto Cool Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10742-8159-1	RohtoCool Max	1 in 1 CARTON	LIQUID	1		9
10742-8159-1	RohtoCool Max	13 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	13		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10742-8159	ROHTO COOL MAX (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY]	9	Legacy NDC, 2 package rows	20241219_20b934af-fe24-44a2-b313-5540a209432c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAPHAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	MZ1131787D	2
POLYSORBATE 80	ACTIVE INGREDIENT	6OZP39ZG8H	2
NAPHAZOLINE	ACTIVE MOIETY	H231GF11BV	2
POLYSORBATE 80	ACTIVE MOIETY	6OZP39ZG8H	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	2
CHLOROBUTANOL	INACTIVE INGREDIENT	HM4YQM8WRC	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	2
POTASSIUM ASPARTATE	INACTIVE INGREDIENT	OC4598NZEQ	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10742-8159	10742-8159-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
CHLOROBUTANOL	HM4YQM8WRC	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
POTASSIUM ASPARTATE	OC4598NZEQ	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
NAPHAZOLINE HYDROCHLORIDE	MZ1131787D	ACTIB
POLYSORBATE 80	6OZP39ZG8H	ACTIB
ALCOHOL	3K9958V90M	IACT

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
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CHLOROBUTANOL	CHLOROBUTANOL	HM4YQM8WRC	INJECTION / INTRAVENOUS		60 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	SOLUTION / AURICULAR (OTIC)	0.3 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.3 %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	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	SUSPENSION/ DROPS / OPHTHALMIC	0.03 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	GEL / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	SOLUTION/ DROPS / OPHTHALMIC	1.1 %w/v		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	LOTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		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	DROPS / NASAL	0.1 mg/1ml		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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 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
54819ad1-e5d0-d021-e063-6294a90a05ef			20b934af-fe24-44a2-b313-5540a209432c	2026-06-18	Warnings	Exact identifier spl set id: 20b934af-fe24-44a2-b313-5540a209432c

Reported adverse events (FAERS/openFDA)#

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