Label: CBDMEDIC BACK AND NECK PAIN RELIEF- camphor and menthol ointment

  • NDC Code(s): 73096-745-02, 73096-745-04, 73096-745-07, 73096-745-40
  • Packager: ABACUS HEALTH PRODUCTS, INC.
  • 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 28, 2022

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  • Active Ingredients and Purpose

    Camphor 10%, Menthol 15% (External Analgesics)

  • PURPOSE

  • Uses

    Temporary relief of minor aches and pains of muscles and joints associated with simple backache, neck and shoulder strains

  • 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

    Cottonseed oil, beeswax, CBD hemp oil, clove oil, eucalyptus oil, jojoba seed oil, peppermint oil, tea tree oil, sorbic acid

  • Questions?

    Call 1-844-422-3633

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CBDMEDIC BACK AND NECK PAIN RELIEF 
    camphor and menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73096-745
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)100 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    CLOVE OIL (UNII: 578389D6D0)  
    COTTONSEED OIL (UNII: H3E878020N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HEMP (UNII: TD1MUT01Q7)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SORBIC ACID (UNII: X045WJ989B)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73096-745-401 in 1 CARTON09/01/2019
    140 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73096-745-071 in 1 BLISTER PACK02/01/2020
    27 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:73096-745-042 in 1 BLISTER PACK02/01/2020
    31.7 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:73096-745-021.7 g in 1 PACKET; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2019
    Labeler - ABACUS HEALTH PRODUCTS, INC. (116931574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(73096-745)
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