Other
MOUTH RINSE
Mouth Rinse
FDA Label NDC 83566-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Aimu Biological Technology Co., Ltd for the product Mouth Rinse (NDC 83566-201). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%
Otc - Purpose
Clean the oral cavity and prevent oral diseases
Indications & Usage
Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.
Warnings
Do not swallow, please keep out of reach of children.
For use only by people aged six and above.
Otc - Do Not Use
Do not use under the age of six, and do not use if there is a wound in the mouth.
Otc - When Using
Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.
Otc - Stop Use
If adverse reactions occur during use, please seek medical assistance immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Applicable population: Children over 6 years oldStorage conditions: Store in a cool and dry place,avoiding direct sunlight
Storage And Handling
Storage conditions: Store in a cool and dry place,avoiding direct sunlight
Inactive Ingredient
WATER
CETYLPYRIDINIUM CHLORIDE
POLOXAMER 407
POTASSIUM SORBATE
SUCRALOSE
SODIUM BENZOATE
SODIUM SACCHARIN
CITRIC ACID
CI42090
Package Label.Principal Display Panel
Label (10ml)
Label2 (12ml)
Label3 (12ml 2)
Label4 (480ml)
Label5 (300ml)
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