Label: CBD UNLIMITED MISTX TOPICAL ANALGESIC- menthol and camphor spray

  • 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 January 25, 2021

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  • Active ingredient

    Menthol USP 5%
    Camphor 3.25%

  • Purpose

    Topical Analgesic

  • Inactive ingredients

    Arnica Oil, Clove Bud Oil, Eucalyptus Globus Oil, Hemp, Isopropyl Alcohol, MSM (Methylsulfonylmethane), Peppermint Oil, Sweet Birch Oil.

  • Uses

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

  • Warnings:

    For external use only.

    Flammable: Keep away from excessive heat or open flame.

    Do not use on wounds or damaged skin.

    When using this product: Avoid contact with the eyes. Do not bandage tightly.

    Stop use and ask a doctor ifcondition worsens, or if  symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast-feeding ask a health professional before use. 

  • Keep Out of Reach of Children

    If product is swallowed get medical help or contact a Poison Control Center right away.

  • Keep Out of Reach of Children

    If product is swallowed get medical help or contact a Poison Control Center right away.

  • Directions:

    Adults and children 12 years of age & older. Spray a thin flim over affected area not more than 3 to 4 times daily: massage not necessary, for children 12 years or younger, consult a doctor.

  • Distributed By: 

    CBD UNLIMITED INC

  • Principal Display Panel

    CBD UNLIMITED MISTX 

    TOPICAL ANALGESIC

    1 fl. oz. (30mL) Spray

    Label-1

    Label-2

  • INGREDIENTS AND APPEARANCE
    CBD UNLIMITED MISTX TOPICAL ANALGESIC 
    menthol and camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73045-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 mL
    CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL3.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEMP (UNII: TD1MUT01Q7)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CLOVE OIL (UNII: 578389D6D0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73045-002-3030 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/12/2019
    Labeler - ENDEXX CORPORATION (002119594)
    Registrant - ENDEXX CORPORATION (002119594)
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