Label: CBD PAIN RELIEF CLINICAL STRENGTH MENTHOL FORMULA- menthol, unspecified form gel

  • Category: HUMAN OTC DRUG LABEL

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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 foot, ankle and leg pain associated with arthritis

    • muscle aches
    • muscle strains
    • muscle sprains
    • 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

    HOTWORX®
    24 HOUR INFRARED FITNESS STUDIO

    planet beach®
    spray & spa

  • PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

    ROLL ON

    CBD
    PAIN RELIEF

    Clinical Strength Menthol Formula

    DISTRIBUTED BY

    HOTWORX®
    24 HOUR INFRARED FITNESS STUDIO

    planet beach®
    spray & spa

    150mg CBD 3 fl oz (88 mL)

    PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CBD PAIN RELIEF   CLINICAL STRENGTH MENTHOL FORMULA
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72593-157
    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:72593-157-1288 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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