Label: FIRST SHIELD- benzalkonium chloride, lidocaine hci cream

  • NDC Code(s): 49314-0003-1, 49314-0003-2
  • Packager: Unishield
  • 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 April 3, 2023

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • Purpose

    First aid antiseptic

    Topical analgesic

  • Uses

    • temporary relief of pain associated with minor burns
    • helps protect against harmful bacteria
  • Warnings

    For external use only.

  • Do not use

    • in eyes
    • in large quantities
    • over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, serious burns
    • for more than one week unless directed by a doctor
  • Keep out of reach of children.

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

  • Directions

    • clean affected area
    • apply a small amount not more than 3-4 times daily
    • children under 2 years: do not use,consult a doctor
  • Other Information

    • store at room temperature (do not freeze)
    • tamper evident sealed packets
    • do not use any opened or torn packets

  • Inactive ingredients

    aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA,ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol,purified water, PEG-100 Stearate, phenoxyethanol, stearic acid, triethanolamine

  • Questions or comments?

    1-800-480-5855

  • PRINCIPAL DISPLAY PANEL

    image of pouch labelimage of box label

  • INGREDIENTS AND APPEARANCE
    FIRST SHIELD 
    benzalkonium chloride, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-0003-225 in 1 BOX04/03/2023
    1NDC:49314-0003-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/03/2023
    Labeler - Unishield (790677053)
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