Inactive Ingredient
aqua
glycerin
propylene glycol
allantoin
polysorbate 20
sophora flavescens root extract
phenoxyethanol
ethylhexylglycerin
sodium citrate
menthol
citric acid
Mouth Ulcer Liquid
FDA Label NDC 87714-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Shengli Shidai Cosmetics Co., Ltd. for the product Mouth Ulcer (NDC 87714-002). 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 inactive ingredient, dosage & administration, warnings, otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
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.
Warnings
It is contraindicated for individuals who are allergic to this product or any of its ingredients.
Otc - Active Ingredient
panthenol 1.2%
Otc - Keep Out Of Reach Of Children
Please keep it out of reach of children to prevent them from taking or eating.
Otc - Purpose
Relieve oral discomfort
Indications & Usage
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.
Package Label.Principal Display Panel
Label Image (22)
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