FDA.reportPublic FDA data

MILAN

Manufacturer
CBDVELVET LLC
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:57:23

Label at a glance#

ProductMILAN
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Aid for temporary local relief of minor pain in muscles or joints associated with general backpain, strains, sprains and bruises.

Dosage and administration

Adults and children over 16 years of age. Apply to affected area not more than three to four times daily. Children 16 years of age or younger, consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic.

Warnings

WARNINGS SECTION

For external use only,

  • Avoid Contact with eyes.
  • Do not apply to wounds or damaged skin.
  • If symptoms persist for more than seven days discontinue use and consult a physician. 
  • If pregnant or breastfeeding contact a health professional before use.
  • keep out of reach of children.If swallowed get  medical help or contact a poison control right away.

Emergency Number: 1-800-222-1222

Uses

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints associated with general backpain, strains, sprains and bruises.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 16 years of age.
  • Apply to affected area not more than three to four times daily.
  • Children 16 years of age or younger, consult a physician.

Other Information

SPL UNCLASSIFIED SECTION

Store in a cool, dry place with lid closed tightly.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Emu Oil, Alcohol Denat., Stearic Acid, Glycerin, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Caprylyl Glycol,Phenoxyethanol Hexylene Glycol, Squalane, Stearyl Alcohol, Hemp-Derived Cannabidiol (CBD), Sodium Hyroxide, Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract, Arnica Montana Flower Extract.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81019-002-022025-01-14C16284748780-1f386c649-a942-0266-e053-dadaa90a7c1aff41f36c-7908-4cef-b0c2-62b0eed64ce3
81019-002-022023-01-30C16284748780-1f386c649-a942-0266-e053-dadaa90a7c1aff41f36c-7908-4cef-b0c2-62b0eed64ce3

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81019-00281019-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EMU OIL344821WD61IACT
ALCOHOL3K9958V90MIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
SQUALANEGW89575KF9IACT
STEARYL ALCOHOL2KR89I4H1YIACT
CANNABIDIOL19GBJ60SN5IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
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
2b5e5af9-1398-8608-e063-6294a90a0458ff41f36c-7908-4cef-b0c2-62b0eed64ce32025-01-10WarningsExact identifier
spl set id: ff41f36c-7908-4cef-b0c2-62b0eed64ce3

Reported adverse events (FAERS/openFDA)#

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