Label: CBD MENTHOL PAIN RELIEF FAST ACTING PAIN ROLLER- menthol, unspecified form gel

  • 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, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Natural Menthol, USP (8.5%)

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves muscle and joint pain associated with arthritis

    • muscle aches
    • muscle strains
    • joint pain.
  • Warnings

    For external use only: Flammable: Keep away from excessive heat or open flame

    • Ask a doctor before use if you have sensitive skin or if you are taking any blood thinners

    • When using this product: Do not use on wounds or irritated skin
    • Do not bandage tightly or use with a heating pad
    • Wash hands after use with cool water

    • If pregnant or breastfeeding: Ask a health professional before use

    • Keep out of reach of children. If accidentally swallowed, contact a doctor or poison control center immediately

    • Stop use and ask a doctor: If condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.
  • Directions

    Use only as directed

    • Do not use on children under 12 years of age
    • Roll onto affected area no more than four times daily
    • Shake well before each use.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis Extract, Isopropyl Alcohol, Methyl Sulfonylmethane, Peppermint Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Purified Water, Triethanolamine

  • Other Information

    Questions or comments?

    Call (877) 383-2334. Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

  • SPL UNCLASSIFIED SECTION

    Distributed by FORE

  • PRINCIPAL DISPLAY PANEL - 88 ml Bottle Label

    FORE

    150MG
    CBD
    Menthol
    PAIN
    RELIEF
    Fast-Acting Pain Roller

    Net Wt. 3 fl oz (88 ml)

    Principal Display Panel - 88 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    CBD MENTHOL PAIN RELIEF   FAST ACTING PAIN ROLLER
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72593-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM85 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72593-158-1288 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/05/2020
    Labeler - Global Products Group, LLC (081371764)
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