Drug Fact
Active Ingredient
Benzocaine 20%
Mouth Sore Relief Applicator
FDA Label NDC 65734-867
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Swabplus Inc. for the product Mouth Sore Relief Applicator (NDC 65734-867). 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 drug fact, purpose, uses, warning allergy alert, when using this product, stop use and ask a doctor if, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Reliever
Uses
temporarily relieves these symptoms. cold sores. scanker sores. fever blisters. minor irritation or injury of the mouth and gums.
Warning 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.
When Using This Product
avoid eye contact. do not exceed recommended dosage. do not use more than 7 days unless told to do so by a dentist or doctor.
Stop Use And Ask A Doctor If
swelling. rash or fever develops, irritation, pain, or redness persists or worsen.
Do not use on children under 2 years except underteh advice and supervision of a doctor.
Keep Out Of The Reach Of Children
if swallowed get medical help or contact a Poison Contro;mCenter right away.
Directions
Snap the tip at the color ring. Allow formula to flow down to the opposite tip. Apply formula with the saturated tip to affected area
Other Information
Avoid storaging at excessive heat.
Inactive Ingredient
Polyethylene glycol 400 (PEG-8), Glycerin, Saccharin sodium, water, pina Colada
Package Label.Principal Display Panel
Image of carton label
Image Of Mouth Sore Label (Mouthsore300867)
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