FDA.reportPublic FDA data

Menthol Davis Topical Analgesic Ointment

Manufacturer
Genia Care Phamaceutical S.A.
Effective date
2022-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:04

Label at a glance#

ProductMenthol Davis Analgesic
Active ingredientMENTHOL
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

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

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store in a cool, dry, ventilated place, away from all sources of heat, ignition, and combustion.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Paraffin wax, petrolatum.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2664060menthol 5 % Topical OintmentPSN1
2664060menthol 0.05 MG/MG Topical OintmentSCD1
2664060menthol 5 % Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82480-000-012024-01-30C16284748780-11030e365-5d8a-111a-e063-dadaa90a10e2Menthol Davis Topical Analgesic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82480-000-01Menthol Davis Analgesic28 g in 1 CANOINTMENT281
82480-000-01Menthol Davis Analgesic1 in 1 BLISTER PACKOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82480-000MENTHOL DAVIS ANALGESIC (MENTHOL) OINTMENT [GENIA CARE PHAMACEUTICAL S.A.]12 package rows20230904_b809ccd5-c5de-4bb4-b8e9-7a1402208989.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82480-00082480-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
MENTHOLL7T10EIP3AACTIB

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
e15c1756-d723-5c44-e053-2a95a90a179ab809ccd5-c5de-4bb4-b8e9-7a14022089892022-06-13WarningsExact identifier
spl id: e15c1756-d723-5c44-e053-2a95a90a179a
spl set id: b809ccd5-c5de-4bb4-b8e9-7a1402208989

Reported adverse events (FAERS/openFDA)#

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