Label: LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT- lidocaine hcl and menthol spray

  • 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 June 27, 2018

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  • SPL UNCLASSIFIED SECTION

    LIDOCAINE AND MENTHOL - Lidocaine HCl 4% and Menthol 4% topical spray
    7T Pharma, LLC 

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    Lidocaine 4% and Menthol 4% Topical Spray

    ​Drug Facts

  • Active ingredient

    Lidocaine HCl 4%

    Menthol 4%

  • Purpose

    Topical anesthetic
    Topical analgesic

  • Uses

    Temporarily relieves pain and itching due to:

    • minor cuts
    • sunburn
    • minor scrapes
    • minor burns
    • insect bites
    • minor skin irritations
  • Warnings

    ​For external use only.

    When using this product

    • do not use in or near the eyes
    • do not use in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase

    Keep out of reach of children.

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

  • Directions

     adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
     children under 2 years ask a doctor
  • Other information

    • May be applied under occlusive dressing.
    • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.
  • Inactive ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B

    Lidocaine 4% and Menthol 4% Topical Spray

    NDC 70645-263-11

    4 fl oz (118mL)

    Manufactured for:
    7T Pharma, LLC
    Los Angeles, CA 90064

  • PRINCIPAL DISPLAY PANEL

    NDC 70645-263-11
    LIDOCAINE 4%
    AND
    MENTHOL 4%
    topical spray
    4 Fl oz. (118 mL)

    PRINCIPAL DISPLAY PANEL NDC 70645-263-11 LIDOCAINE 4% AND MENTHOL 4% topical spray 4 Fl oz. (118 mL)

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT 
    lidocaine hcl and menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70645-263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70645-263-11118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/01/2018
    Labeler - 7T Pharma LLC (080220022)
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