MILAN by CBDVELVET LLC 81019-002-02

MILAN by

Drug Labeling and Warnings

MILAN by is a Otc medication manufactured, distributed, or labeled by CBDVELVET LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MILAN- menthol cream 
CBDVELVET LLC

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81019-002-02

Active Ingredients

Menthol 4%

Purpose

Topical analgesic.

Warnings

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

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

Directions

• 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

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

Inactive Ingredients

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

MILAN 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81019-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EMU OIL (UNII: 344821WD61)
ALCOHOL (UNII: 3K9958V90M)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SQUALANE (UNII: GW89575KF9)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CANNABIDIOL (UNII: 19GBJ60SN5)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81019-002-02	100 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/20/2020	11/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/20/2020	11/20/2022

Labeler - CBDVELVET LLC (117698368)

Revised: 1/2025

Document Id: 2b5e5af9-1398-8608-e063-6294a90a0458

34390-5

Set id: ff41f36c-7908-4cef-b0c2-62b0eed64ce3

Version: 2

Effective Time: 20250110