Theracare Maximum Strength Oral Pain Relief
FDA Label NDC 71101-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Maximum Strength Oral Pain Relief (NDC 71101-201). 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 ingredients, purpose, use, warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

Oral pain reliever

Antiseptic

Use

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

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

Otc - Do Not Use

Do not use

  • more than directed
  • for more than 7 days unless directed by a physician or healthcare provider

Otc - Ask Doctor

Stop use and ask a physician 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 (1-800-222-1222)

Dosage & Administration

Directions

  • Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
  • Children under 12 years of age - Should be supervised in the use of this product
  • Children under 2 years of age - Ask a physician or healthcare provider

Other Information

  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • do not use if tube seal under cap is broken
  • store at 20-25C (68-77F)

Inactive Ingredients

Glycerin, polyethylene glycol, saccharin sodium, sodium polyacrylate, sorbic acid, sorbitol, strawberry furanone, water.

Questions Or Comments?

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