Label: ALOE VERA GEL- lidocaine hcl, 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 April 5, 2022

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

  • Active ingredient

    Lidocaine HCl 0.7%

    Menthol 0.2%

  • Purpose

    topical analgesic

  • Uses

    for the temporary relief of pain and itching associated with

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

    For external use only

  • When using this product

    avoid contact with the eyes

  • do not use

    in large quantities, particularly over raw surfaces or blistered areas

  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

  • 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 of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • inactive ingredients

    water, alcohol, glycerin, polysorbate 80, carbomer, Aloe barbadensis leaf juice, benzophenone-4, triethanolamine, imidazolidinyl urea, blue 1

  • claims

    Made in the USA

    with US and foreign parts

  • Adverse Reactions Section

    Manufactured by: Vi-Jon, LLC

    St. Louis, MO 63114

    Questions or Comments?

    1-888-593-0593

  • principal display panel

    mountain

    falls

    cools &

    soothes

    with

    lidocaine

    & menthol

    relieving

    after sun

    aloe gel

    topical analgesic

    16 FL OZ (473 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ALOE VERA GEL 
    lidocaine hcl, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-747
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    IMIDUREA (UNII: M629807ATL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-747-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/24/2017
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-747)