Dentek Instant Pain Relief Maximum Strength Liquid
FDA Label NDC 60630-078

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dentek Oral Care, Inc. for the product Dentek Instant Pain Relief Maximum Strength (NDC 60630-078). 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 active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a dentist or doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzocaine 20%

Purpose

Oral pain reliever

Use

for the temporary relief of pain due to:

  • toothaches
  • canker sores
  • cold sores
  • sore gums

Warnings

METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy

    • 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. If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • for teething
  • in children under 2 years of age

When Using This Product

  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use 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, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

dip applicator into liquid

Adults and children 2 years and olderApply a small amount of product to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.
Children between 2 and 12 years Should be supervised in the use of this product.
Children under 2 years Do not use.

     

Other Information

  • for toothaches, use only as a temporary remedy until a dentist can be seen
  • store at 20-25⁰C (68-77⁰F).

Inactive Ingredients

Peppermint Oil, Polyethylene Glycol 400, Spearmint Oil, Sucralose

Principal Display Panel

DenTek™

INSTANT PAIN RELIEF

Benzocaine 20% / ORAL ANESTHETIC

1 BOTTLE OF BENZOCAINE 0.118 fl oz (3.5 mL), 1 CASE, 50 APPLICATORS, 1 HANDLE

Principal Display Paneldentek™ Instant Pain Relief Benzocaine 20% / Oral Anesthetic1 Bottle Of Benzocaine 0.118 Fl Oz (3.5 mL), 1 Case, 50 Applicators, 1 Handle (Dentek Instant Pain Relief 60630 078 01 01)

Principal Display Paneldentek™ Instant Pain Relief Benzocaine 20% / Oral Anesthetic1 Bottle Of Benzocaine 0.118 Fl Oz (3.5 mL), 1 Case, 50 Applicators, 1 Handle (Dentek Instant Pain Relief 60630 078 01 01)

* Please review the disclaimer below.