Label: FIRST AID ANTISEPTIC PAIN RELIEVING- benzalkonium chloride, lidocaine hydrochloride cream

  • NDC Code(s): 82996-002-01, 82996-002-02
  • Packager: Hubei Changjian Medical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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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 withminor 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

  • Package labeling: 82996-002-01

    First Aid Antiseptic Pain Relieving Cream 82996-002-01

  • Package labeling: 82996-002-02

    First Aid Antiseptic Pain Relieving Cream 82996-002-02

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC PAIN RELIEVING 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82996-002
    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) LIDOCAINE HYDROCHLORIDE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82996-002-010.9 g in 1 POUCH; Type 0: Not a Combination Product11/01/2022
    2NDC:82996-002-023.5 g in 1 POUCH; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/01/2022
    Labeler - Hubei Changjian Medical Products Co., Ltd. (699440035)
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