Label: SUNBURN RELIEF 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 September 27, 2023

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  • 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 clean 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, diazolidinyl urea, menthol, disodium EDTA, blue 1, yellow 5

  • disclaimer

    DISTRIBUTED BY:

    Amazon.com Services, Inc.

    Seattle, WA 98109 1-877-485-0385

    2018 Amazon.com Services, Inc. or its affiliates

    All rights reserved. Solimo and all related logos are trademarks of Amazon.com, Inc. or its affiliates

  • principal display panel

    CVS

    Health

    Compare to the active ingredient in Solarcaine Cool Aloe Relief Formula

    Burn

    Relief Gel

    LIDOCAIND HCl 0.5%

    Pain Relieving Gel

    Moisturizing Gel

    • Soothes & relieves
    • Cools & soothes sunburned skin
    • Paraben free

    NET WT 8 OZ (226 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNBURN RELIEF GEL 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5.05 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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MENTHOL (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-909-34226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2018
    Labeler - CVS (062312574)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(69842-909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(69842-909)
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