PM EXTERNAL

Manufacturer
OASIS TRADING
Effective date
2019-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:54

Label at a glance#

ProductPM EXTERNAL
Active ingredientLEVOMENTHOL, SALICYLIC ACID, LIDOCAINE, ECONAZOLE NITRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL

OTC - PURPOSE SECTION

When left untreated, the symptoms can be painful, unsightly, and make walking difficult.
Here are the most common symptoms:
Itching or burning between your toes or on the soles of your feet
White, wet-looking skin in between your toes
Flaky skin or small tears (fissures) on feet or in-between toes
Red rash between the toes
Blisters or ulcers on the skin on top of foot
Broken blisters, causing pain and swelling
Thick, dry, scaly skin on the bottom and sides of feet

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

■First wash and dry your feet thoroughly
■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
■ children under 2 years of age: consult a doctor

WARNINGS SECTION

For external use olny.
Flammable
■ Keep away from fire, flame, sparks and heated surfaces.
Tight cap firmly
Stop use and ask a doctor if
■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days
When using this product
■ use olny as direct
■ avoid contact with eyes
■ Do not apply to wounds or damage skin
■ do not bandage tightly
If pregnant or breast-feeding, ask a health professional before use
keep out of reach of children.

INACTIVE INGREDIENT SECTION

acetone, chloroxylenol, water

DOSAGE & ADMINISTRATION SECTION

For external use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ECONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
e3a04dc3-1a9e-4fba-b2b4-a18279351082Product name220180620
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
aa7deb41-117b-479c-8362-130fd1c222deProduct name120160112
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72689-0038-12021-01-29C16284748780-1ba0f9c33-582f-a910-e053-dadaa90a0b85846a49a1-c31e-73b9-e053-2a91aa0a0f95

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72689-0038-1PM EXTERNAL70 mL in 1 BOTTLE, PLASTICSOLUTION701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72689-0038PM EXTERNAL (ECONAZOLE NITRATE, SALICYLIC ACID, LIDOCAINE, L-MENTHOL) SOLUTION [OASIS TRADING]1Legacy NDC, 1 package rows20190319_846a49a1-c31e-73b9-e053-2a91aa0a0f95.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72689-003872689-0038-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
846c196a-5b4e-08d4-e053-2991aa0a4d85846a49a1-c31e-73b9-e053-2a91aa0a0f952019-03-19WarningsExact identifier
spl id: 846c196a-5b4e-08d4-e053-2991aa0a4d85
spl set id: 846a49a1-c31e-73b9-e053-2a91aa0a0f95

Reported adverse events (FAERS/openFDA)#

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