Label: ANTISEPTIC- benzalkonium chloride, lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 14, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzalkonium

    Chloride 0.13% w/w

    Lidocaine

    HCI 0.5% w/w

  • 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 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 contact a Poison Control Center right away

  • Directions

    • clean affected area
    • apply small amount not more than 3 times daily
    • children under 2: consult a doctor
  • Inactive ingredients

    aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

  • Principal Display Panel – Pouch Label

    BE SMART

    GET PREPARED

    BURN
    CREAM
    W/ ALOE VERA • FOR MINOR BURNS

    0.03 oz [0.90 g]

    SINGLE USE

    Made in USA • Mfd. for: TOTAL RESOURCES INTL.
    Walnut, California 91789

    00-BUR-0009 Rev.01 • NDC #55550-902-21

    Figure
  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride1.3 mg  in 1 g
    lidocaine hydrochloride (UNII: V13007Z41A) (lidocaine - UNII:98PI200987) lidocaine hydrochloride anhydrous5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    alcohol (UNII: 3K9958V90M)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    petrolatum (UNII: 4T6H12BN9U)  
    white wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55550-902-210.9 g in 1 POUCH; Type 0: Not a Combination Product01/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/14/2020
    Labeler - Total Resources International (790160535)
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