Label: CBDMEDIC MASSAGE THERAPY PAIN RELIEF- camphor and menthol oil

  • 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 December 25, 2019

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  • Active Ingredients and Purpose

    Camphor 3.1%, Menthol 4% (External Analgesics)

  • PURPOSE

  • Uses

    Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

  • 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
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation develops
    If pregnant or breast-feeding
    ask a health professional before use
    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years of age and older:
    • apply to affected area not more than 3 to 4 times daily
    • wash hands with soap and water after use (unless applying to hands)
    Children under 12 years of age: ask a doctor

  • Inactive ingredients

    Jojoba seed oil, cottonseed oil, frankincense oil, CBD hemp oil, honeysuckle oil, myrrh oil, argan oil, coconut oil (MCT oil)

  • Questions?

    Call 1-844-422-3633

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CBDMEDIC MASSAGE THERAPY PAIN RELIEF 
    camphor and menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)31 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    COTTONSEED OIL (UNII: H3E878020N)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    HEMP (UNII: TD1MUT01Q7)  
    LONICERA CONFUSA WHOLE (UNII: 22L2C7GWOA)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MYRRH OIL (UNII: H74221J5J4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-750-041 in 1 CARTON07/01/2019
    1103 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2019
    Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-750) , label(24909-750)
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