Label: SUNBURN RELIEF- lidocaine hcl 0.5% 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 October 4, 2022

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

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

  • QUESTIONS

    Questions?  1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY Walmart Inc., Bentonville, AR 72716

    *This product is not manufactured or distributed by Bayer Healthcare,

    LLC, owner of the registered trademark Solarcaine

    Cool Aloe Burn Relief Formula.

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

  • Principal Display Panel

    NDC 79903-037-34

    EquateTM

    Compare to Solarcaine Cool Aloe Burn Relief Formula active ingredient*

    Burn

    Relief Gel

    WITH LIDOCAINE

    Pain Relieving Gel

    with Aloe

    Empty & Replace Cap

    PLASTIC BOTTLE

    how2recycle.info

    Relief from:

    • sunburn
    • Cuts & scrapes
    • Insect bites

    Moisturizer

    NET WT 8 OZ (226g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNBURN RELIEF 
    lidocaine hcl 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    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:79903-037-34226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/23/2020
    Labeler - WALMART INC. (051957769)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(79903-037)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(79903-037)