Label: FIRST AID ANTISEPTIC PAIN RELIEVING BENZALKONIUM CHLORIDE LIDOCAINE HYDROCHLORIDE- benzalkonium chloride, lidocaine hydrochloride cream

  • NDC Code(s): 84219-002-00
  • Packager: M-star (Hubei) Health&Care Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 1, 2024

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  • Drug Facts

  • Active ingredients

    Benzalkonium chloride 0.13%

    Lidocaine hydrochloride 0.5%

    Purpose

    First aid antiseptic 

    Pain relieving cream

  • Uses

    • First aid to help prevent infection in minor cuts scrapes and burns.
    • For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.
  • Warnings

    For external use only. 

    Do not use

    • in the eyes
    • over large areas of the body
    • in large quantities 
    • over raw surfaces or blistered areas 
    • longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • animal bites
    • deep or puncture wounds 
    • serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse.
    • symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

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

  • Directions

    • clean the affected area.
    • Adults and children 2 years of age and older. Apply a small amount of this product to affected area not more than 3 times daily.
    • Children under 2 years of age consult a doctor.
    • May be covered with a sterile bandage.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    glycerin monostearate, glycerol, purified water

  • Question?

    +1(855)924-2182

  • 84219-002-00

    Label3.jpg

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC PAIN RELIEVING BENZALKONIUM CHLORIDE LIDOCAINE HYDROCHLORIDE 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84219-002
    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) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84219-002-000.9 g in 1 POUCH; Type 0: Not a Combination Product05/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/15/2024
    Labeler - M-star (Hubei) Health&Care Products Co., Ltd. (409376382)
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