CBDMEDIC ARTHRITIS PAIN RELIEF- menthol. cream 
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CBDMEDIC Arthritis Pain Relief

Active Ingredient and Purpose

Menthol 4% (External Analgesic)

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis.

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: • avoid contact with eyes or mucous membranes • do not bandage tightly or use with a heating pad. Stop use and ask a doctor if: • condition worsens, or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • excessive skin irritation develops.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center immediately.

Directions

Adults and children 12 years of age and older: massage cream into affected area not more than 3 to 4 times daily. Wash hands with soap and water after use. Children under 12 years of age: ask a doctor.

Inactive ingredients

Beeswax (organic), clove oil, cotton seed oil, emulsifying wax, eucalyptus oil, hemp extract (THC-free), jojoba seed oil, peppermint oil, purified water, shea butter, sorbic acid, tea tree oil

PRINCIPAL DISPLAY PANEL

image description

CBDMEDIC ARTHRITIS PAIN RELIEF 
menthol. cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-740
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
CLOVE OIL (UNII: 578389D6D0)  
COTTONSEED OIL (UNII: H3E878020N)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HEMP (UNII: TD1MUT01Q7)  
JOJOBA OIL (UNII: 724GKU717M)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
SORBIC ACID (UNII: X045WJ989B)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-740-481 in 1 CARTON03/04/2019
148 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2019
Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-740) , label(24909-740)

Revised: 3/2019
Document Id: 6badb356-4530-4d9c-82d3-a085ec56e11c
Set id: 9f131395-b6c0-41ce-8447-4cde56d96d05
Version: 1
Effective Time: 20190312
 
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC