Label: SAFLY BURN- lidocaine hydrochloride cream

  • NDC Code(s): 43473-039-01
  • Packager: Nantong Health & Beyond Hygienic Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 17, 2024

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

    Lidocaine HCI         0.5%

  • PURPOSE

    Purpose

    First Aid Antiseptic
    Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    Temporary relief of pain associated 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
    • may be covered with a sterile bandage
  • STORAGE AND HANDLING

    Other Information

    • store at room temperature
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PÉG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SAFLY BURN 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43473-039-010.9 g in 1 PACKET; Type 0: Not a Combination Product05/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/17/2024
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-039)
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