Label: GREEN GUARD TOPICAL PAIN RELIEF- lidocaine hci spray

  • NDC Code(s): 78495-132-01
  • Packager: Ultra Distributors Inc
  • 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 December 20, 2020

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  • 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 a Poison Control Center right away.

  • Directions

    • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
    • not to be used on Children under 12 years of age

  • Inactive ingredients

    glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

  • Questions or comments?

    1-800-869-6970

  • SPL UNCLASSIFIED SECTION

    Topical Pain Relief

    Relieves pain of minor burns

    Store at 68°-77°F (20°-25°C)

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD TOPICAL PAIN RELIEF 
    lidocaine hci spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78495-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78495-132-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/19/2020
    Labeler - Ultra Distributors Inc (007160073)
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