Onetouch Revolution
FDA Label NDC 62565-802

9 label sections · Submitted to the FDA by Hager Worldwide, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hager Worldwide, Inc. for the product Onetouch Revolution (NDC 62565-802). 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 ingridients (in each gram), purpose, use, warnings, directions, other information, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingridients (In Each Gram)

Benzocaine 20%

Purpose

Oral Anesthetic

Use

Temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic devices

Warnings

Methemoglobinemia warning:

Use of this product may cause methemoglobinemia, a rare but 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 they 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

    • Do not exceed reccommended dosage

Directions

Adults and children 12 years and over. Press top of container and dispense 0.2 mL. Apply 0.2 mL of gel to the desired area using a cotton swab.

Children under 12 should be supervised by an adult.

Children under 2 years of age, consult a doctor.

Other Information

Store at room temperature
20˚-25˚ C (68˚ - 77˚ F).

Protect from freezing.

Inactive Ingredients

Propylene glycol, polyethylene glycol, carbomer, sodium saccharin, povidone, flavoring and FD&C Red No. 40.

Questions Or Comments

Contact Hager Worldwide at (800) 328-2335

Principal Display Panel - Jar Label

NDC 62565-802-01
OneTouch
Revolution

Topical Anesthetic Gel

OneTouch Revolution is indicated for anesthesia of accessible mucous membrane.

Strawberry Ice

Net Wt. 1.12 oz (32 g)

Principal Display Panel (Jar Label)

Principal Display Panel (Jar Label)

Principal Display Panel (29.6 mL Jar Label)

Principal Display Panel (29.6 mL Jar Label)

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