Rohto

Manufacturer
Rohto Pharmaceutical Co., Ltd. | The Mentholatum Company
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:18

Label at a glance#

ProductRohto Dual Light Relief
Active ingredientPOVIDONE, HYPROMELLOSE, UNSPECIFIED
Label structure8 sections

Indications and uses

for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun protects against further irritation or to relieve dryness of the eye

Dosage and administration

put 1 or 2 drops in the affected eye(s) as needed tightly snap on cap to seal Other information do not store above 25 OC (77 OF)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hypromellose 0.3%

Povidone 0.5%

Purpose

OTC - PURPOSE SECTION

Hypromellose – Lubricant

Povidone - Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • protects against further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

For external use only

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

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 persists for 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) as needed
  • tightly snap on cap to seal

Other information

  • do not store above 25 OC (77 OF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image 01Image 01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2604775hypromellose 0.3 % / povidone 0.5 % Ophthalmic SolutionPSN2
2604775hypromellose 3 MG/ML / povidone 5 MG/ML Ophthalmic SolutionSCD2
2604775hypromellose 0.3 % / povidone 0.5 % Ophthalmic SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66613-8459-1RohtoDual Light Relief1 in 1 CARTONLIQUID12
66613-8459-1RohtoDual Light Relief18 mL in 1 BOTTLE, DISPENSINGLIQUID182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66613-8459ROHTO DUAL LIGHT RELIEF (HYPROMELLOSE, POVIDONE) LIQUID [ROHTO PHARMACEUTICAL CO., LTD.]22 package rows20241222_1bbde83e-a64e-1a0f-e063-6394a90af4ff.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66613-845966613-8459-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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
29ab2269-62a8-00b9-e063-6394a90aaf5b1bbde83e-a64e-1a0f-e063-6394a90af4ff2024-12-19WarningsExact identifier
spl id: 29ab2269-62a8-00b9-e063-6394a90aaf5b
spl set id: 1bbde83e-a64e-1a0f-e063-6394a90af4ff

Reported adverse events (FAERS/openFDA)#

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