Label: ZAPOTOL DENTIDOL ORAL ANALGESIC- benzocaine, and benzalkonium chloride gel

  • 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 November 1, 2016

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!