MOUTH ULCER

MOUTH ULCER is an FDA-registered drug product whose active ingredient is PANTHENOL. It is labelled by Guangzhou Shengli Shidai Cosmetics Co., Ltd. taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 87714-002, application M022, label effective 20260522. It is one of 2 FDA drug label records sharing the active ingredient PANTHENOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PANTHENOL are most often described in connection with: temporary relief, pain due, canker sores, gums caused, dentures orthodontic, appliances minor, children years, older eapply. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

For the temporary relief of pain due to canker sores, mínor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums. Adults and children 2 years of age and older:eApply a small amount directly to the affected area 3 to 4 times daily,or as needed.Do not eat or drink for at least 1 minute after application.Children under 12 years old should use under adult supervision.Children under 2 years: Do not use.

Adults and children 2 years of age and older:eApply a small ámount directly to the affected area 3 to 4 times daily,or as needed,Do not eat or drink for at least 1 minute after application.Children under 12 years old should use under adult supervision.Children under 2 years: Do not use.

It is contraindicated for individuals who are allergic to this product or any of its ingredients.

FDA lists 2 drug label records with PANTHENOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is MOUTH ULCER used for?
For the temporary relief of pain due to canker sores, mínor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums. Adults and children 2 years of age and older:eApply a small amount directly to the affected area 3 to 4 times daily,or as needed.Do not eat or drink for at least 1 minute after application.Children under 12 years old …

Who makes MOUTH ULCER?
Guangzhou Shengli Shidai Cosmetics Co., Ltd. is the labeler of record for MOUTH ULCER. 2 FDA label records share the active ingredient PANTHENOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does MOUTH ULCER come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is MOUTH ULCER prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PANTHENOL?
Yes. 2 FDA drug label records list PANTHENOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has MOUTH ULCER been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.