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 3, 2022

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  • Active ingredient

    Lidocaine HCl 0.5%

  • Purpose

    External analgesic

  • Use

    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

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by Bayer

    distributer of Solarcaine Cool Aloe Burn Relief Formula

    DISTRIBUTED BY: RITE AID

    30 HUNTER LANE

    CAMP HILL, PA 17011

    www.riteaid.com

    SATISFACTION GUARANTEE:

    If you're not satisfied,

    we'll happily

    refund your money.

  • Principal Panel Display

    Compare to Salarcaine

    Cool Aloe Burn Relief Formula

    Pain Relieving Gel

    with Lidocaine HCI*

    SUNBURN

    RELIEF 

    PAIN RELIEVING GEL

    WITH ALOE

    Cool on contact

    Great sunburn relief

    Minor burn relief

    NET WT 

    8 OZ (226 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNBURN RELIEF 
    lidocaine hcl 0.5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0776
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  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)  
    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:11822-0776-3226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/30/2019
    Labeler - Rite Aid (014578892)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11822-0776)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11822-0776)
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