Label: ALOCANE EMERGENCY BURN- lidocaine hydrochloride gel

  • NDC Code(s): 68229-201-01, 68229-201-02, 68229-201-03, 68229-201-04, view more
    68229-201-05, 68229-201-06, 68229-201-07, 68229-201-08, 68229-201-09, 68229-201-10, 68229-201-11, 68229-201-12, 68229-201-13, 68229-201-14, 68229-201-15, 68229-201-16, 68229-201-17, 68229-201-18
  • 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

    Lidocaine HCL 4%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of pain and itching associated with:

    • Sunburn
    • Minor Skin Irritation
    • Minor Burns
    • Cuts & Scrapes
    • Insect Bites
  • 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.

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

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

    Directions:

    Adults and Children 2 years of age or older:

    • Clean the burn area with mild soap and water
    • Gently apply over bthe burn or wound
    • Use on affected area not more than 3 to 4 times daily

    Children under 2 years of age: Consult a doctor

  • Other Information

    Store at room temperature 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 - ALOCANE Burn Gel 2.5 fl oz tube

    201-02

  • PRINCIPAL DISPLAY PANEL -- ALOCANE Burn Gel Pump

    201-14

  • PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel Single Use 45 Count

    45SingleUse

  • PRINCIPAL DISPLAY PANEL - ALOCANE Burn Spray 3.5 fl oz

    201.08

  • INGREDIENTS AND APPEARANCE
    ALOCANE EMERGENCY BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-201
    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
    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:68229-201-021 in 1 CARTON03/01/2019
    1NDC:68229-201-01110 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68229-201-03110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
    3NDC:68229-201-0524 in 1 CARTON03/01/2020
    3NDC:68229-201-043.4 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:68229-201-0745 in 1 CARTON03/01/2020
    4NDC:68229-201-063.4 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:68229-201-08103.507 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
    6NDC:68229-201-11133.081 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
    7NDC:68229-201-101 in 1 CARTON03/01/2019
    7NDC:68229-201-09118.294 mL in 1 TUBE; Type 0: Not a Combination Product
    8NDC:68229-201-14946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/201912/31/2024
    9NDC:68229-201-121 in 1 KIT03/01/201909/30/2022
    9NDC:68229-201-15800 mL in 1 BAG; Type 0: Not a Combination Product
    10NDC:68229-201-131 in 1 CARTON03/01/2019
    10NDC:68229-201-15800 mL in 1 BAG; Type 0: Not a Combination Product
    11NDC:68229-201-181 in 1 CARTON12/09/2021
    11NDC:68229-201-1722 mL in 1 TUBE; Type 0: Not a Combination Product
    12NDC:68229-201-16124 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2019
    Labeler - Quest Products, LLC. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-201)
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