Label: FIRST SHIELD- benzalkonium chloride, lidocaine hci cream

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

Drug Label Information

Updated January 15, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 0.5%

  • PURPOSE

    Purpose

    First Aid Antiseptic

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    • Temporary relief of pain associated with minor cuts, scrapes, and burns.
    • Helps protect against harmful bacteria.
  • WARNINGS

    Warnings

    For external use only.

    If swallowed, get medical help or contact a Poison Control Center directly.

  • DO NOT USE

    Do not use

    • in eyes
    • in large quantities
    • over raw or blisteres areas, or on deep puncture wounds, animal bites, or serious burns
    • for more than one week unless directed by a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • clean affected area
    • apply small amount not more than 3 times daily
    • may be covered with a sterile bandage
  • OTHER SAFETY INFORMATION

    Other Information

    • store in a cool dry area 15° to 25C° (59° to 79°F)
    • tampler evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    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

    Questions?

    Call: 800-325-4655

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    FIRST SHIELD 
    benzalkonium chloride, lidocaine hci cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72976-008
    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:72976-008-010.9 g in 1 POUCH; Type 0: Not a Combination Product11/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00511/23/2022
    Labeler - Ever Ready First Aid (147372960)
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