BURN WITH ALOE (LIDOCAINE HYDROCHLORIDE) SPRAY [PROVISION MEDICAL]

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BURN WITH ALOE (LIDOCAINE HYDROCHLORIDE) SPRAY [PROVISION MEDICAL]
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NDC 69103-3500-1
Set ID 2a08a5af-7146-433b-9874-1e5f66c2c3a8
Category HUMAN OTC DRUG LABEL
Packager Provision Medical
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 HCI 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 cleaned 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

  • Principal Display Panel - Bottle Label

    with aloe vera

    BURN SPRAY

    Relieves Pain in Minor Burns

    Washable

    Package Not Child Resistant

    2 fl. oz. (59.15ml)

    Manufactured for

    Provision Medical Products Palm Desert, CA 92211

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    BURN WITH ALOE 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous200 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    methylparaben (UNII: A2I8C7HI9T)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-3500-10.05915 L in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/29/2014
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-3500)
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