SUNBURN RELIEF GEL (LIDOCAINE HCL) GEL [VI-JON, INC]

SUNBURN RELIEF GEL (LIDOCAINE HCL) GEL [VI-JON, INC]
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NDC 0869-0005-34
Set ID 3a5e5012-e77a-48a1-b4b1-706ab39ca178
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • 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

  • 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, 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

    Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

    Questions or comments?  1-888-593-0593

    Made in the USA with US and foreign parts

  • principal display panel

    Mountain falls

    *Compare to Solarcaine

    with aloe vera

    helps returned moisture to sunburned skin

    with lidocaine HCl

    doctor tested

    SUNBURN RELIEF GEL

    PAIN RELIEVING GEL

    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:0869-0005
    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)  
    CARBOXYPOLYMETHYLENE (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:0869-0005-34226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/10/2017
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0005)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0005)

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