Drug Facts

Manufacturer: The Mentholatum Company | Rohto-Mentholatum (Vietnam) Co. Ltd.
Effective date: 2026-06-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: monthly-update
Hydrated at: 2026-07-17 21:34:54

Label at a glance#

ProductRohto Cool Relief

Active ingredientNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80

Label structure8 sections

Indications and uses

relieves redness of the eye due to minor eye irritations for use as a lubricant to prevent further irritation or to relieve 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 0.012%

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
for use as a lubricant to prevent further irritation or to relieve 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 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 - 5 PM (EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0310742010749	GTIN-13: 0310742010749 EAN-13: 0310742010749 GTIN-12: 310742010749 UPC-A: 310742010749 GTIN storage (14 digits): 00310742010749	image-01.jpg
QR code link	QR Code	www.rohtoreviews.com/		image-01.jpg

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
10742-8141-1	2023-02-08	C162847	48780-1	f386c64a-2be5-0266-e053-dadaa90a7c1a	Drug Facts
10742-8141-1	2023-02-08	C162847	48780-1	f386c64a-2be5-0266-e053-dadaa90a7c1a	Drug Facts
10742-8141-1	2023-01-30	C162847	48780-1	f386c64a-2be5-0266-e053-dadaa90a7c1a	Drug Facts
10742-8141-1	2023-01-30	C162847	48780-1	f386c64a-2be5-0266-e053-dadaa90a7c1a	Drug Facts

Products#

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

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

Rohto Cool Relief
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
10742-8141	10742-8141-1

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

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2024-12-17	full-release	2026-06-01 00:44:20

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
Rohto Cool Relief	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30	2026-06-19	Warnings	Exact identifier ndc (package): 10742-8141-1 ndc (product): 10742-8141 ndc11 (package): 10742814101 spl id: 54a037ff-1157-92f5-e063-6294a90a4de0 spl set id: dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30

Reported adverse events (FAERS/openFDA)#

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