Label: CBD UNLIMITED BALM TOPICAL ANALGESIC- 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 May 5, 2020

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  • Active ingredient

    Menthol 1.25%

  • Purpose

    Topical Analgesic

  • Uses

     For the temporary relief of minor aches and
    pains of muscles and joints associated with arthritis, backache, strains and sprains.

  • Warnings:

    Warnings: For external use only.

    When using this product:
    • use only as directed

    • do not bandage tightly or use with a heating pad

    • avoid contact with eyes and mucous membranes

    • do not apply to wounds or damaged, broken or irritated skin

    • do not spray onto face

    • avoid inhaling spray mist and fumes

    Stop use and ask doctor if

    • condition worsens

    • redness is present

    • irritation develops

    • symptoms persist for more than 7 days or clears up and occurs again within a few days

    Flammable

    • do not use near heat or open _ame or while smoking

    If pregnant or breast-feeding, ask a healthcare

    professional before use.

    Keep out of the reach of children

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions:

    Adults and children 12 years of age and older: Apply on affected areas 1 to 4 times daily.

    Avoid contact with eyes & mouth.

  • Inactive Ingredients

    Arnica Extract (Glycerin, Water, Arnica Montana Flower Extract), Beeswax, Clove Bud Oil, Grapeseed Oil, Hemp-Derived Cannabadiol Isolate, Hemp Seed Oil, Lavender Oil, Methylsulfonylmethane (MSM), MCT Coconut Oil, Lemongrass Oil, Moringa Oil, Sweet Birch Oil

  • Image

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    CBD UNLIMITED BALM TOPICAL ANALGESIC 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73045-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL125 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)  
    Clove Oil (UNII: 578389D6D0)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    East Indian Lemongrass Oil (UNII: UP0M8M3VZW)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73045-003-0160 mL in 1 JAR; Type 0: Not a Combination Product05/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2020
    Labeler - ENDEXX CORPORATION (002119594)
    Registrant - ENDEXX CORPORATION (002119594)
    Establishment
    NameAddressID/FEIBusiness Operations
    Velocity Production & Packaging081076893MANUFACTURE(73045-003)
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