Quala Topical Anesthetic Gel
FDA Label NDC 68400-479

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. for the product Quala Topical Anesthetic Gel (NDC 68400-479). 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, directions, otc - keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzocaine 200mg (in each g)

Purpose

Oral Anesthetic

Use

For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.

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 the 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 on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
    Do not use

    • for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
    • for teething
    • in children under 2 years of age

      • When using this product Avoid contact with eyes. If contact occurs, flush with water.

      Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
      If pregnant or breast feeding, ask a physician before use.

Directions

  • Apply only amount needed to the oral mucosa to prevent or relieve pain.
  • children under 2 years of age: do not use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

Store at 59°-86°F (15°-30°C). Protect from freezing.

Inactive Ingredients

flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow #5, (tartrazine), yellow #6, as a color additive.

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