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 22, 2022

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  • 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 under2 years of age: ask a doctor
  • inactive ingredients

    water, alcohol denat., polysorbate 20, glycerin, Aloe barbadensis leaf juice, carbomer, benzophenone-4, triethanolamine, benzyl alcohol, phenoxyethanol, blue 1

  • Adverse Reactions Section

    Questions 1-888-593-0593

    DIST. BY MEIJER

    DISTRIBUTION, INC

    GRAND RAPIDS, MI 49544

    www. meijer.com

  • principal display panel

    meijer

    Cooling

    Aloe Vera Gel

    Topical Analgesic Gel

    With Lidocaine

    and Menthol

    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:41250-747
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4.97 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-747-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/29/2016
    Labeler - Meijer Distribution (006959555)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41250-747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-747)
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