Label: ALOE VERA GEL- lidocaine hcl, menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 February 28, 2023

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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

  • do not use

    in large quantities, particularly over raw surfaces or blistered areas

  • when using this product

    avoid contact with the eyes

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    The Kroger Co. Cincinnati, Ohio 45202

    Quality guarantee

    800-652-6900 www.kroger.com

    DSP-TN-15000 DSP-MO-34 SDS-TN-15012

    747.000/747AA

  • principal display panel

    Kroger

    Cooling Gel with aloe vera

    with Lidocaine and Menthol

    Helps to soothe sunburned skin

    cools and moisturizes

    NET 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:30142-747
    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)  
    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:30142-747-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/24/2021
    Labeler - The Kroger Co (006999528)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(30142-747)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(30142-747)
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