Label: CANNABICOOL PAIN RELIEVING LIDOCAINE ROLL-ON- lidocaine hcl 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 14, 2022

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  • ​Active Ingredient

    Lidocaine HCl  4%

  • ​Purpose

    Topical Anesthetic

  • Uses

    For the temporary relief of pain and itching.

  • WARNINGS

    ​For external use only.

  • SAFE HANDLING WARNING

    ​Flammable

    Keep away from fire or open flame.

  • DO NOT USE

    ​Do not use

    • In large quantities, particularly over raw surfaces or blistered areas.
    • If you are allergic to any of the ingredients in this product.
  • WHEN USING

    ​When using this product

    • ​Avoid contact with eyes.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

  • STOP USE

    ​Stop use and ask a doctor if

    • Condition worsens.
    • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • PREGNANCY OR BREAST FEEDING

    ​If pregnant or breast-feeding,​ ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    ​Directions

    ​Adults and children over 12 years:

    • ​Apply to affected area not more than 3 to 4 times daily.  If medicine comes in contact with hands, wash with soap and water.
    • For children under 12 years of age: ask a doctor.

  • OTHER SAFETY INFORMATION

    ​Other information

    • ​​Store tightly closed in a cool, dry place.

  • INACTIVE INGREDIENT

    ​Inactive ingredients

    ​​Aloe Barbadensis (Aloe Vera) Gel, Beta Caryophyllene, Boswellia Carterii Resin Extract, Calendula Officinalis Flower Extract, Cannabis Sativa Seed Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Nigella Sativa (Black Cumin) Seed Oil, Silica, Tocopheryl Acetate, Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Label 1Label 2

  • INGREDIENTS AND APPEARANCE
    CANNABICOOL PAIN RELIEVING LIDOCAINE ROLL-ON 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76209-567
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDAMIDINE HYDROCHLORIDE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76209-567-0188 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2019
    Labeler - Market America, Inc. (797412236)
    Registrant - A.I.G. Technologies, Inc. (086365223)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.086365223manufacture(76209-567) , label(76209-567)
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