UNBURN (LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES]

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UNBURN (LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES]
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NDC 59898-500-10, 59898-500-14
Set ID 0c504ba8-8a40-43dd-8c68-62ed106b32a2
Category HUMAN OTC DRUG LABEL
Packager Water-Jel Technologies
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active ingredient

    Lidocaine HCl 2.5%

  • Purpose

    External analgesic

  • Uses

    for the temporary relief of pain associated with:

    • sunburn
    • minor burns
    • minor skin irritations
    • insect bites
  • 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 eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of the 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: consult a doctor
  • Other information

    • store at 15 o to 25 oC (59 o to 77 oF)
    • do not freeze
    • you may report a serious adverse reaction to this product to 1-800-275-3433
  • Inactive ingredients

    acrylates/C20-30 alkyl acrylate crosspolymer, aloe, carbomer, diazolidnyl urea, edetate disodium, glyceryl-7 stearate, methylparaben, octoxynol-9, polysorbate 20, propylene glycol, propylparaben, purified water, spearmint oil, tea tree oil, trolamine, vitamin E acetate

  • QUESTIONS

    1-800-275-3433

    Monday - Friday (9a.m. - 5 p.m. EST)

    www.unburn.info

  • Principle Display Panel

    Unburn

  • INGREDIENTS AND APPEARANCE
    UNBURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-500-1059 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/17/2013
    2NDC:59898-500-14240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/17/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/17/2013
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-500)
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