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Drug Facts

Manufacturer
The Mentholatum Company | Rohto-Mentholatum (Vietnam) Co. Ltd.
Effective date
2026-08-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-08-22 01:01:37

Label at a glance#

ProductRohto Max Strength
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)

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 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, potassium aspartate, 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

Image 1Image 1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130310742011012GTIN-13: 0310742011012
EAN-13: 0310742011012
GTIN-12: 310742011012
UPC-A: 310742011012
GTIN storage (14 digits): 00310742011012		CA570001 - Rohto Max Strength.jpg
QR code linkQR Codewww.rohtoreviews.com/CA570001 - Rohto Max Strength.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8158-12023-02-08C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-12023-02-08C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-12023-02-08C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-22023-02-08C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-22023-02-08C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-22023-02-08C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-12023-01-30C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-12023-01-30C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-12023-01-30C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-22023-01-30C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-22023-01-30C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts
10742-8158-22023-01-30C16284748780-1f386c649-9e78-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-815810742-8158-1, 10742-8158-2

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
NameUNIIKind
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
POLYSORBATE 806OZP39ZG8HACTIB
ALCOHOL3K9958V90MIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
CHLOROBUTANOLHM4YQM8WRCIACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POTASSIUM ASPARTATEOC4598NZEQIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-06-03daily-update2026-06-06 05:10:14
42024-12-17full-release2026-06-01 00:44:21

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
ndc (package): 10742-8158-1
ndc (package): 10742-8158-2
ndc (product): 10742-8158
ndc11 (package): 10742815801
ndc11 (package): 10742815802
spl id: 597624b2-ba16-52c5-e063-6294a90a5ee3
spl set id: e4b49550-1ca3-4bd7-854d-409b53fa5e26

Reported adverse events (FAERS/openFDA)#

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