Label: ALOCANE PLUS- lidocaine hydrochloride and benzalkonium chloride ointment

  • NDC Code(s): 68229-300-01, 68229-300-02, 68229-300-03
  • Packager: Quest Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Lidocaine HCL 4%Topical Analgesic
    Benzalkonium Chloride 0.13%Topical Antiseptic
  • Uses

    For the temporary relief of pain and itching associated with: Sunburn, Minor Burns, Insect Bites and minor Skin Irritation, Cuts and Scrapes.

  • Warnings

    For external use only. Avoid contact with eyes.

    Keep out of reach of children.

    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.

  • Directions

    Adults and children 2 years of age or older

    Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age, consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas.

  • Other Information

    Store in a cool, dry area.

  • Inactive Ingredients

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    QUEST
    PRODUCTS
    Gurnee, IL USA

  • PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

    ALOCANE®
    plus

    Topical Anesthetic/Anti-Microbial
    Lidocaine HCL 4%
    Benzalkonium Chloride 0.13%

    FOR TOPICAL USE ONLY

    Store at controlled room temperature
    59° - 86° F (15° - 30° C)
    KEEP OUT OF REACH OF CHILDREN

    DISTRIBUTED BY
    QUEST
    PRODUCTS

    2oz (59mL)

    Principal Display Panel - 59 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ALOCANE PLUS 
    lidocaine hydrochloride and benzalkonium chloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-300
    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:68229-300-0250 in 1 BOX12/11/2013
    1NDC:68229-300-013.55 mL in 1 DOSE PACK; Type 0: Not a Combination Product
    2NDC:68229-300-031 in 1 CARTON03/01/2020
    259 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34812/11/2013
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855MANUFACTURE(68229-300)
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