Label: CBD PAIN FREEZE SHRINK- menthol 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 March 24, 2022

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  • 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 PACKAGE12/15/202001/31/2024
    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 not finalpart34812/15/202001/31/2024
    Labeler - Global Widget, LLC (089584863)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Widget, LLC089584863manufacture(73423-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Widget LLC118504011manufacture(73423-003)
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