Active Ingredient
Benzocaine 20%
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Mouth Sore Relief (NDC 59779-830). 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 ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzocaine 20%
Oral Anesthetic/Analgesic
for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums
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 blood. This can oocur even if you have use this product before. stop ise and seek immediate medical attention if you or a child in you care develops:
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
Do not use:
When using this product
Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
• do not purchase if package has been opened
• cap tightly after use to avoid evaporation
• avoid contact with eyes
• avoid contact with clothing and household/furniture surfaces to prevent possible staining
• this is a personal care item, and should be used by one individual only
Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamide/acrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, polyethylene glycol, Propylene Glycol, Ricinus Communis (Castor) seed Oil, SD Alcohol 38B, Sucralose,Tannic Acid
* Please review the disclaimer below.