Zapotol Dentidol Oral Analgesic
FDA Label NDC 59428-500

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Productos Zapotol Corp. for the product Zapotol Dentidol Oral Analgesic (NDC 59428-500). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                                                                  Purpose

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

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

Otc - 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.

Otc - Do Not Use

Do not use

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

Otc - 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

Otc - 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

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