Label: GREEN GUARD BURN- lidocaine hcl spray

  • NDC Code(s): 47682-320-02
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Lidocaine HCl 2.0%

  • PURPOSE

    Purpose

    External analgesic

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of pain associated with minor burns

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use in large quantities, particularly over raw or blisterd areas

  • WHEN USING

    When using this product avoid contact with eyes

  • STOP USE

    Stop use and ask a 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

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3-4times daily
    • children under 2 years: consult a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature
    • you may report a serious adverse reaction to this product to 1-800-869-6970
  • INACTIVE INGREDIENT

    Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, tea tree oil, trolamine, water

  • PRINCIPAL DISPLAY PANEL

    Burn Spray

    Lidocaine HCl 2.0%

    Topical Pain Relief

    Rekieves pain of minor burns

    Store at room temperature

    Green Guard®

    2 fl oz (59.1 mL)

    Burn Spray

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD BURN 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-320
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-320-020.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/202105/20/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01506/01/202105/20/2025
    Labeler - Unifirst First Aid Corporation (832947092)