BURN RELIEF (LIDOCAINE) SPRAY [AMERISOURCE BERGEN]

BURN RELIEF (LIDOCAINE) SPRAY [AMERISOURCE BERGEN]
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NDC 24385-777-04
Set ID 77072d8c-080d-4a3d-8733-ea25aee765cf
Category HUMAN OTC DRUG LABEL
Packager Amerisource Bergen
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                     Purpose
    Lidocaine 0.5%.........................External analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pain and itching associated with: • sunburn
    • minor burns • minor cuts • scrapes • insect bites • minor skin irritations

  • WARNINGS

    Warnings
    For external use only.
    Flammable: Do not use near heat, flame, or while smoking.
    Do not use in large quantities, particularly over raw surfaces or blistered areas.
    When using this product • keep away from face to avoid breathing it. • avoid
    contact with eyes. • use only as directed. • do not puncture or incinerate.
    Contents under pressure. Do not store at temperatures above 120ºF.
    If condition worsens or if symptoms persist for more than 7 days or clear up and
    occur again within a few days, discontinue use of this product and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions • Shake well • 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 • Do not spray directly into face; spray into palm of hand and
    gently apply

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl
    Urea, Disodium Cocoamphodipropionate, Disodium EDTA, Glycerin, Methylparaben,
    Propylene Glycol, Propylparaben, SD Alcohol 40, Simethicone, Tocopheryl Acetate,
    Triethanolamine.

  • Questions? 610-727-7000

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-777-04128 g in 1 CAN; Type 0: Not a Combination Product03/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2012
    Labeler - Amerisource Bergen (007914906)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(24385-777) , label(24385-777)

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