Label: 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 September 3, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    for the temporary pain of relief associated with minor burns

  • Warnings

    For external use only

    Do not use

    in large quantities, particularly over raw surfaces or blistered areas

    • near eyes, if this happens rinse thoroughly with water

    Stop use and ask doctor if

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

    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: to affected area not more than 3-4 times daily
    • children under 2 years: consult a doctor
  • Other information

    • store at room temperature
  • Inactive ingredients

    aloe vera, germaben II, propylene glycol, purified water

  • Questions or Comments?

    1-800-327-2704

  • Principal Display Panel - Bottle Label

    Burn
    Spray

    Lidocaine HCl 2%
    Water-Soluble

    Convenient pump
    spray allows no-touch
    application. Use as a
    first aid treatment for
    minor burns, scalds &
    sunburn.

    2 fl. oz. (59.1 mL)

    Xpect®
    First aid

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-5100
    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:68421-5100-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2013
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(68421-5100)
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