ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.]

ZAPOTOL DENTIDOL ORAL ANALGESIC (BENZOCAINE, AND BENZALKONIUM CHLORIDE) GEL [PRODUCTOS ZAPOTOL CORP.]
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NDC 59428-500-42
Set ID 1368d8bd-4263-4d8f-8a44-20571a8d6f8c
Category HUMAN OTC DRUG LABEL
Packager Productos Zapotol Corp.
Generic Name
Product Class
Product Number
Application Number PART356
  • ACTIVE INGREDIENT

    Active ingredients                                                                  Purpose

    Benzocaine 20%.................................................................. Oral pain reliever

    Benzalkonium chloride 0.1%................................................. Antiseptic

  • PURPOSE

    Uses

    • temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters, minor irritation of the mouth and gums caused by dentures or orthodontic appliances.
    • to help protect against infection in minor oral irritation.
  • WARNINGS

    Warnings

    Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a doctor/dentist
  • STOP USE

    Stop use and ask a dentist or doctor if

    • swelling, rash, or fever develops
    • irritation, pain, or redness persists or worsens
    • symptoms do not improve in 7 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    • remove cap and cut tip of tube on score mark
    • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by doctor or dentist.
    • children under 12 years of age should be supervised in the use of this product
    • children under 2 years of age: ask a doctor/dentist
  • STORAGE AND HANDLING

    Other information

    • store at 15°-25°C (59°-77°F)
    • do not use if tube tip is cut prior to opening
    • this preparation is intended for use in cases of toothaches, only as temporary expedient until a dentist can be consulted.
    • do not use continuously
    • Lot No. & Exp Date: see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive ingredients

    glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Productos Zapotol Corp.

    Palmdale, CA 93550

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ZAPOTOL DENTIDOL ORAL ANALGESIC 
    benzocaine, and benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59428-500-421 in 1 PACKAGE11/01/2016
    111.9 g in 1 CARTON; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/18/2015
    Labeler - Productos Zapotol Corp. (186063850)

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