FDA.reportPublic FDA data

menthol

Manufacturer
PHYTOPIA CO., LTD.
Effective date
2016-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:12

Label at a glance#

Productmenthol
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Helps relieve the condition of cellulitis infection.

Dosage and administration

Apply on skin and gentle massage around infected area.

Label contents#

Full prescribing information#

active ingredient

OTC - ACTIVE INGREDIENT SECTION

menthol(1%) analgesic, External
Uses

Uses

OTC - PURPOSE SECTION

Helps relieve the condition of cellulitis infection.

Dosage Suggestion

DOSAGE & ADMINISTRATION SECTION

Adults 10ml maximum per day, Children 5ml maximum per day

Directions

INDICATIONS & USAGE SECTION

Apply on skin and gentle massage around infected area.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Thyme Oil, Peppermint Oil, Lemon Oil, Lavender Oil, Geranium Oil (Algerian Type), Olive Oil, Almond Oil, Sunflower Oil, Evening Primrose Oil, Calendula Officinalis Seed Oil.

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • For external use only.
  • Stop use and ask doctor if rash occurs.
  • Keep out reach of children.

Warning

WARNINGS SECTION

Keep out reach of children.

Other Information

SAFE HANDLING WARNING SECTION

Protect this product from excessive heat and direct sun.

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

factfact

allall

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1739888menthol 1 % Topical OilPSN1
1739888menthol 10 MG/ML Topical OilSCD1
1739888menthol 1 % Topical OilSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70470-1011-52020-01-31C16284748780-19d75b9d0-31a5-f424-e053-dadaa90a57ce2c010c2e-d876-4a72-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70470-1011-5menthol50 mL in 1 BOTTLE, DROPPEROIL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70470-1011MENTHOL (CELLULITICA) OIL [PHYTOPIA CO., LTD.]1Legacy NDC, 1 package rows20160229_2c010c2e-d876-4a72-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70470-101170470-1011-5

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
NameUNIIKind
CALENDULA OFFICINALIS SEED OIL9JS8DS42SVIACT
ALMOND OIL66YXD4DKO9IACT
PHENOL339NCG44TVIACT
MENTHOLL7T10EIP3AACTIB
OLIVE OIL6UYK2W1W1EIACT
LEMON OILI9GRO824LLIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
LAVENDER OILZBP1YXW0H8IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT

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
2c010c2e-d877-4a72-e054-00144ff88e882c010c2e-d876-4a72-e054-00144ff88e882016-02-17WarningsExact identifier
spl id: 2c010c2e-d877-4a72-e054-00144ff88e88
spl set id: 2c010c2e-d876-4a72-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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