Label: ANTISEPTIC- benzalkonium chloride, lidocaine hydrochloride cream

  • 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 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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