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

  • NDC Code(s): 43473-015-01
  • Packager: Nantong Health & Beyond Hygienic Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

    Lidocaine HCL 0.5%

  • PURPOSE

    Purpose

    First Aid Antiseptic

    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporary relief of pain assocoated with minor cuts, scrapes, and burns.

    Helps protect against harmful bacteria

  • WARNINGS

    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, or serious burns
    • for more than one week unless directed by a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center directly.

  • DOSAGE & ADMINISTRATION

    Directions 

    Clean affected area

    Apply small amount not more than 3 times daily

    Maybe covered with a sterile bandage

  • STORAGE AND HANDLING

    Other information

    Store in a cool area 15C to 25C (59F to 77F)

    Temper evident sealed packats

    Do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe barbadensis leaf jiuce, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate/ PEG-100 Stearate, Glycerin, Maltodextrin, Mineral oil, Phenoxyethanol,  Propylene glycol, Water, Stearic acid, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    GENUINE FIRST AID ANTISEPTIC PAIN RELIEVING 
    benzalkonium chloride, lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-015
    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 ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43473-015-010.9 g in 1 POUCH; Type 0: Not a Combination Product10/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/19/2023
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-015)
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