BURN (LIDOCAINE HYDROCHLORIDE) SPRAY [ACME UNITED CORP]

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BURN (LIDOCAINE HYDROCHLORIDE) SPRAY [ACME UNITED CORP]
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NDC 0924-0930-01
Set ID ce9f2aff-6b2a-4193-8046-dac0af0bb5f1
Category HUMAN OTC DRUG LABEL
Packager Acme United Corp
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    temporary pain relief associated with minor burns

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water

    Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

    Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away

  • Directions

    • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
    • for children under 2 years of age: consult a physician
  • Inactive ingredients

    aloe vera, germaben II, propylene glycol, purified water

  • Questions?

    call 203-857-5361

  • Principal Display Panel - Bottle Label

    13-040

    BURNS

    FIRST AID ONLY®

    Burn Spray

    Pain relieving spray
    for use on minor burns

    4 fl oz (118.3ml)

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0930
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0930-010.1183 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/06/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/06/2014
    Labeler - Acme United Corp (001180207)
    Registrant - Safetec of America, Inc (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(0924-0930)
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