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 00:44:08

Label at a glance#

ProductRohto Ice

Active ingredientHYPROMELLOSE, UNSPECIFIED, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE, UNSPECIFIED FORM

Label structure8 sections

Indications and uses

temporarily relieves redness of the eye and discomfort due to minor eyes irritations exposure to wind or sun 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 store at 20-25°C (68-77°F)

Contacts and useful links#

PhoneLabel contact1-877-636-2677

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hypromellose 0.2%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

OTC - PURPOSE SECTION

Hypromellose - Lubricant

Tetrahydrozoline HCl - Redness reliever

Zinc sulfate - Astringent

Uses

INDICATIONS & USAGE SECTION

temporarily relieves redness of the eye and discomfort due to
- minor eyes irritations
- exposure to wind or sun
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 narrow angle glaucoma

When using this product

OTC - WHEN USING 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

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, edetate disodium, menthol, polysorbate 80, 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1098640	hypromellose 0.2 % / tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	PSN	15
1098640	hypromellose 2 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution	SCD	15
1098640	hypromellose 0.2 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution	SY	15
1098640	hypromellose 2 MG/ML / Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution	SY	15

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10742-8143-1	2023-02-08	C162847	48780-1	f386c649-e1eb-0266-e053-dadaa90a7c1a	Drug Facts
10742-8143-1	2023-01-30	C162847	48780-1	f386c649-e1eb-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10742-8143-1	RohtoIce	13 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	13		15
10742-8143-1	RohtoIce	1 in 1 CARTON	LIQUID	1		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10742-8143	ROHTO ICE (HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) LIQUID [THE MENTHOLATUM COMPANY]	15	Legacy NDC, 2 package rows	20241219_209bcec8-fbb4-4079-8ae2-810c48f3de93.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYPROMELLOSES	ACTIVE INGREDIENT	3NXW29V3WO	6
TETRAHYDROZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0YZT43HS7D	6
ZINC SULFATE	ACTIVE INGREDIENT	89DS0H96TB	6
HYPROMELLOSES	ACTIVE MOIETY	3NXW29V3WO	6
TETRAHYDROZOLINE	ACTIVE MOIETY	S9U025Y077	6
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	6
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	6
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	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 Ice
Hypromellose, Tetrahydrozoline hydrochloride, Zinc sulfate
BORIC ACID
EDETATE DISODIUM
MENTHOL, UNSPECIFIED FORM
POLYSORBATE 80
WATER
SODIUM BORATE
HYPROMELLOSE, UNSPECIFIED
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE
ZINC SULFATE, UNSPECIFIED FORM
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10742-8143	10742-8143-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	ACTIB
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB
ZINC SULFATE, UNSPECIFIED FORM	89DS0H96TB	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 · 202 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, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRASYNOVIAL	0.2 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 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	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / AURICULAR (OTIC)		13 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 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	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GEL / TOPICAL		12 mg	Exact identifier — unii candidate 78 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii candidate 78 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	LOTION / TOPICAL		22 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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		4739 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 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
54819bb1-d3a3-c0b1-e063-6294a90adaf5			209bcec8-fbb4-4079-8ae2-810c48f3de93	2026-06-18	Warnings	Exact identifier spl set id: 209bcec8-fbb4-4079-8ae2-810c48f3de93

Reported adverse events (FAERS/openFDA)#

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