Label: FIRST SHIELD- lidocaine hci spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • ACTIVE INGREDIENT

    Active ingredient

    Lidocaine HCI 2.0%

  • PURPOSE

    Purpose

    Topical pain relief

  • INDICATIONS & USAGE

    Uses

    Temporary pain relief associated with minor burns

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • in large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water
  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • spray an over 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 INGREDIENT

    Inactive ingredients glycerin, hydroxypropyl methylcllulose, melaleuce alterniflia (tea tree) leaf oil, octoxynol 9,PEEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

  • QUESTIONS

    Questions or comments？ 800-325-4655

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    FIRST SHIELD 
    lidocaine hci spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72976-004
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72976-004-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/30/2022
    Labeler - Ever Ready First Aid (147372960)
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