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Zapotol Dentidol Oral Analgesic

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g, BENZALKONIUM CHLORIDE .1g in 100g
Labeler: Productos Zapotol Corp.
NDC Code: 59428-500

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.

Active ingredients                                                                  Purpose

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

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

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

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

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

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

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

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 ingredients

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

Distributed by:

Productos Zapotol Corp.

Palmdale, CA 93550

Made in Korea

ZAPOTOL DENTIDOL ORAL ANALGESIC 
benzocaine, and benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
PEPPERMINT OIL 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 4000 
SACCHARIN SODIUM 
SORBITOL 
Packaging
#Item CodePackage Description
1NDC:59428-500-421 CARTON in 1 PACKAGE
111.9 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/18/2015
Labeler - Productos Zapotol Corp. (186063850)

Revised: 11/2016
 
Productos Zapotol Corp.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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