Label: BURN- lidocaine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 13, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    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 area
    • Near eyes, if this happens rinse thoroughly with water

    Stop use and ask 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 a 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

  • PRINCIPAL DISPLAY PANEL

    Burn Spray

    Pain relieving spray for use on minor burns.

    M5082

    3 fl. oz. (88.7 ml.)
    ----------
    FIRST AID ONLY

    Distributed by First Aid Only, Inc.

    Vancouver, WA 96882 USA

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62985-5082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous20 g  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:62985-5082-10.0887 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/13/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/13/2014
    Labeler - First Aid Only, Inc (196551634)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(62985-5082)
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