Otc - Active Ingredient
MENTHA X PIPERITA WHOLE
South Moon Toothache Liquid
FDA Label NDC 84983-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou South Moon Biotechnology Co., Ltd. for the product South Moon Toothache (NDC 84983-005). 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 otc - active ingredient, otc - when using, otc - purpose, otc - do not use, otc - stop use, otc - keep out of reach of children, warnings, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - When Using
Spray directly on the mouth (toothache) For discomfort, 1-3 sprays each time, 2-3 times a day or as needed.
Otc - Purpose
Suitable for daily cleaning and long-lasting oral maintenance of oral discomfort caused by Staphylococcus aureus.
Otc - Do Not Use
Discontinue use if signs of irritation or rash occur.
Otc - Stop Use
Discontinue use if signs of irritation or rash occur.
Otc - Keep Out Of Reach Of Children
Please keep out of reach of children. Do not swallow.
Warnings
Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.
Storage And Handling
Store in a cool and dry place.
Inactive Ingredient
AQUA、GLYCERIN、GLUCONOLACTONE、1,2-HEXANEDIOL、VITAMIN B1、ALLANTOIN
Package Label.Principal Display Panel
Label (1)
* Please review the disclaimer below.
