FDA Label for Onetouch Revolution Topical Anesthetic
View Indications, Usage & Precautions
Onetouch Revolution Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Hager Worldwide, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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)
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