Label: CBD MIST TOPICAL ANESTHETIC- lidocaine hydrochloride liquid

  • NDC Code(s): 73524-095-02
  • Packager: Meneks, Michael dba Doctor Energy, Inc.
  • 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 December 30, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Lidocaine HCl 4.00%

    Purpose

    Topical Analgesic

  • Uses:

    For temporary relief of pain.

  • Warnings:

    • For external use only.

    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    • If swallowed, consult physician.

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas.

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physician.

  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa (Full Spectrum Hemp) Oil, Ethylhexylglycerin, Isopropyl Alcohol, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate 20, Rosmarinus Officinalis (Rosemary) Oil, Simmondsia Chinensis (Jojoba) Oil.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CBD MIST TOPICAL ANESTHETIC 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73524-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ROSEMARY (UNII: IJ67X351P9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73524-095-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2019
    Labeler - Meneks, Michael dba Doctor Energy, Inc. (009963305)