Otc - Active Ingredient
sodium fluoride
Soom Mouthwash
FDA Label NDC 73927-0005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bd Technology Co., Ltd for the product Soom Mouthwash (NDC 73927-0005). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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
Inactive Ingredient
Water
Sodium Fluoride
Allantoin
Erythritol
xylitol
Sodium benzoate
Glycerin
Propylene Glycol
PEG-40 Hydrogenated Castor Oil
L-Menthol
zinc gluconate
sodium citrate
Fragrance
Otc - Purpose
prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF THE CHILDREN
Indications & Usage
spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing
Warnings
For oral use only.
When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.
Stop use and ask a doctor if significant irritation or sensitization develops.
Dosage & Administration
for oral use only
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
