Label: CBDMEDIC ARTHRITIS PAIN RELIEF- menthol. cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 12, 2019

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  • 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.

  • INDICATIONS & USAGE

  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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