Label: ALOCANE PLUS- lidocaine hydrochloride and benzalkonium chloride gel

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

Drug Label Information

Updated November 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

    Lidocaine HCl 4.0%

    Purpose

    First Aid Antiseptic

    Topical Analgesic

  • Uses

    First Aid to help prevent bacterial infection associated with contamination of the skin. Temporarily relieves pain and itching due to:

    • minor cuts
    • scrapes
    • minor burns
  • Warnings

    For external use only. Avoid contact with eyes.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

    Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Stop Use and ask doctor

    if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Do not use:

    in large quantities, particularly over raw surfaces or blistered areas.

    If pregnant or breast-feeding

    ask a health care professional before use.

  • Directions:

    Adults and children 2 years of age or older:

    • Shake well
    • Clean the affected area
    • Spray on the affected area 1 to 3 times daily
    • May be covered with a sterile bandage after drying

    Children under 2 years of age: consult a doctor

  • Other Information

    Store at room temperature of 15° - 30°C (59° - 86°F)

  • Inactive Ingredients

    1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.

  • PRINCIPAL DISPLAY PANEL - 3.5 fl oz Spray

    PDP

  • INGREDIENTS AND APPEARANCE
    ALOCANE PLUS 
    lidocaine hydrochloride and benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-404-01104 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/03/2021
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-404)
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