Label: ALOCANE PLUS- lidocaine hydrochloride and benzalkonium chloride gel

  • NDC Code(s): 68229-300-01, 68229-300-02, 68229-300-03, 68229-300-04
  • Packager: Quest Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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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 Cuts & Scrapes, Minor Skin Irritation, Minor Burns

  • 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

    Directions

    Apply to affected area not more than 3 to 4 times daily. Do not use in large quantities, particularly over raw surfaces or blistered areas.

    Children under 2 years of age, consult a physician.

  • 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.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY

    QUEST PRODUCTS LLC

    Pleasant Prairie, WI 53158

  • PRINCIPAL DISPLAY PANEL - 59 mL Tube Carton

    pdp

  • 946mL Bottle

    PDP

  • INGREDIENTS AND APPEARANCE
    ALOCANE PLUS 
    lidocaine hydrochloride and benzalkonium chloride gel
    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 BOX12/11/201307/12/2021
    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
    3NDC:68229-300-04946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/11/2013
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-300)
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