Label: REFILL 3- benzalkonium chloride, lidocaine hydrochloride cream

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

Drug Label Information

Updated December 21, 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 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

    • deep or puncture wounds • animal bites • 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 reah 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:

    Burn treatment

  • INGREDIENTS AND APPEARANCE
    REFILL 3 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0017-010 in 1 BOX08/10/2016
    10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00308/10/2016
    Labeler - CMC Group Inc. (117201448)
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