Label: ALOCANE EMERGENCY BURN PADS- lidocaine hydrochloride swab

  • NDC Code(s): 68229-403-01, 68229-403-02, 68229-403-03
  • Packager: Quest Products, Inc.
  • 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 Bums
    • Minor Skin Irritation
    • 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 the Alocane• Pad over the 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 15-30ºC (59-86ºF)

  • Inactive Ingredients

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

  • PRINCIPAL DISPLAY PANEL - 10 Pad Box

    pdp

  • INGREDIENTS AND APPEARANCE
    ALOCANE EMERGENCY BURN PADS 
    lidocaine hydrochloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-403
    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)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68229-403-0210 in 1 BOX02/13/2017
    1NDC:68229-403-013 mL in 1 POUCH; Type 0: Not a Combination Product
    2NDC:68229-403-0312 in 1 BOX02/13/2017
    2NDC:68229-403-013 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/13/2017
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA926433855manufacture(68229-403)