Active Ingridients (In Each Gram)
Benzocaine 20%
Onetouch Revolution
FDA Label NDC 62565-801
Full FDA labeling including 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 62565-801). 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, directions, other information, inactive ingredients, questions or comments, principal display panel - jar label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Anesthetic
Use
Temporary relief of minor toothache, pain and sore mouth associated with canker sores, dentures and orthodontic devices
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, ethyl alcohol, methylparaben, propyl paraben, flavoring, D&C Yellow No. 10 and FD&C Blue No. 1.
Questions Or Comments
Contact Hager Worldwide at (800) 328-2335
Principal Display Panel - Jar Label
NDC 62565-801-01
OneTouch
Revolution
Topical Anesthetic Gel
OneTouch Revolution is indicated for anesthesia of accessible mucous membrane.
Cool Mint
Net Wt. 1.12 oz (32 g)
Principal Display Panel (29.6 mL Jar Label)
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