Label: ALOCANE MAX- lidocaine hydrochloride and benzalkonium chloride spray

  • NDC Code(s): 68229-408-01, 68229-408-02, 68229-408-03
  • Packager: Quest Products LLC
  • 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 INGREDIENT

    Active IngredientPurpose

    Benzalkonium Chloride 0.13%

    Lidocaine HCL 4%

    First Aid Antiseptic

    Topical Analgesic
  • Uses:

    First aid to help prevent bacterial icontamination or skin infection, and for temporary relief of pain and itching associated with minor:

    • Burns
    • Cuts
    • Sunburn
    • Scrapes
    • Minor Skin Irritation
  • Warnings

    For external use only.

    Ask a doctor before use if you have:

    • Deep or puncture wounds
    • Animal Bites
    • Serious burns

    Do not use:

    • In or near the eyes
    • In large quantities or over large areas of the body
    • On raw surfaces or blistered areas

    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.

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older: Clean the affected area. Spray a small amount on the affected area 3 to 4 times daily. May be covered with a sterile bandage (let dry first). To apply to the face, spray on palm and apply.

    Children under 2 years of age: ask a doctor.

  • Other Information

    Store at 15°-30°C (59°-86°F)

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL - 3.5 fl oz spray

    3.5ozPDP

  • INGREDIENTS AND APPEARANCE
    ALOCANE MAX 
    lidocaine hydrochloride and benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-408
    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:68229-408-01104 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/15/2023
    2NDC:68229-408-02118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/15/2023
    3NDC:68229-408-03124 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/15/2023
    Labeler - Quest Products LLC (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC926433855manufacture(68229-408)
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