Label: ALOCANE- lidocaine hydrochloride ointment

  • 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 June 14, 2013

If you are a consumer or patient please visit this version.

  • 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 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, Inc. Gurnee, IL 60031

  • PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

    4% Lidocaine
    Maximum Strength

    USED IN HOSPITALS
    BURN CENTERS

    MAXIMUM STRENGTH

    ALOCANE®

    Emergency Burn Gel

    • Fast Pain and Itch Relief
    • Assists the Healing Process
    • Soothing Aloe Gel & Vitamin E
    • Use on Sunburns and First Degree Burns

    Recommended by
    Physicians and Pharmacists

    Aloe
    BRAZILIAN

    MADE IN THE
    USA

    Net Wt 2.5 fl. oz
    (75ml)

    Principal Display Panel - 75 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    ALOCANE 
    lidocaine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68229-200
    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:68229-200-021 in 1 CARTON
    1NDC:68229-200-0175 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2013
    Labeler - Quest Products, Inc. (075402441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fill Tech USA965596435MANUFACTURE(68229-200)