Label: ALOE VERA GEL- lidocaine hcl 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 August 26, 2021

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

  • Active ingredient

    Lidocaine HCl 0.5%

  • Purpose

    External 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, propylene glycol, glycerin Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol,  menthol, disodium EDTA, blue 1, yellow 5

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Bayer, distributor of Solarcaine Cool Aloe Burn Relief Formula

    Questions 1-888-593-0593
    DIST BY MEIJER DISTRIBUTION, INC
    GRAND RAPIDS, MI 49544
    www. meijer.com

  • principal display panel

    meijer

    Sunburn Relief Aloe Vera Gel Pain Relieving Gel With Lidocaine

    Compare to Solarcaine*

    NET WT 8 OZ (226 g)

    image description

  • INGREDIENTS AND APPEARANCE
    ALOE VERA GEL 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-093-34226 g 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(41250-093)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41250-093)