Label: CBD PAIN FREEZE SHRINK- menthol gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 11, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Menthol USP  4%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of  pain

  • Warnings

    FOR EXTERNAL USE ONLY

    Do not use:

    • On eyes or on mucous membranes
    • On wounds, damaged or irritated skin
    • If you are allergic to Menthol or any of the ingredients listed below

    When using this product:

    • Use only as directed
    • Do not bandage or cover with any type of wrap except clothing
    • Do not use with heating pad or devices, or apply external heat

    Stop use and ask a doctor if

    • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding: Do not use this product.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults 18 years & over rub a thin layer into affected areas up to 4 times daily.

    Wash hands after application.

  • Other Information:

    Store in cool, dry place away from direct sunlight

    Do not use if seal is broken or not present

  • Inactive Ingredients

    Water, Isopropyl Alcohol, Carbomer, Pure CBD Extract, Triethanolamine

  • Distributed by

    Global Widget, LLC

    8419 Sunstate Street, Tampa, FL 33634

  • Principal Display Panel

    HEMP

    BOMBS

    CBD Pain Freeze Shrink

    MENTHOL 4%

    1 OZ (28 g)

    label

    image description

  • INGREDIENTS AND APPEARANCE
    CBD PAIN FREEZE SHRINK 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73423-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CANNABIDIOL (UNII: 19GBJ60SN5)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73423-003-0112 in 1 PACKAGE12/15/202009/30/2025
    128 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/15/202009/30/2025
    Labeler - Global Widget, LLC (089584863)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Widget, LLC089584863manufacture(73423-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Widget LLC118504011manufacture(73423-003)