Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Lucella Co.,ltd
ORAL
OTC DRUG
Purpose: Anticaries & Anticavity Uses: Helps protect against cavities
OTC monograph final
BON SCENT SPARKLING TOOTH WASH- SODIUM FLUORIDE TABLET LUCELLA CO.,LTD _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- ACTIVE INGREDIENT Active ingredients: Sodium Fluoride 1.1% INACTIVE INGREDIENT Inactive ingredients: DL-Malic acid, DL-Camphor, Glyceryl Monostearate, Glycyrrhizinic acid, Sodium Lauroyl Sarcosinate, Mannitol, Menthol, peppermint oil, Sodium Saccharin dihydrate, Magnesium stearate, Xylitol, Tricalcium phosphate, Calcium Carbonate, Colloid Silica, Sodium bicarbonate, PEG-150, Enzymatically Modified Stevia, Hydroxypropylmethylcellulose PURPOSE Purpose: Anticaries & Anticavity WARNINGS Warnings: - Keep in a cool and dry place. - Do not swallow. - The fluorine content is 583.21ppm. (Total content should be less than 1,000ppm) - If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately. - Keep out of the reach of children under 6 years. KEEP OUT OF REACH OF CHILDREN Keep out of the reach of children under 6 years. US ES Uses: Helps protect against cavities DIRECTIONS Directions: - Put 1 tablet into your mouth and wash your gums, teeth, and tongue using your tongue and lips. -Lastly rinse several times with water. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL BON SCENT SPARKLING TOOTH WASH sodium fluoride tablet PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:728 6 9 -0 10 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 9 .38 mg in 8 53 mg INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MA NNITO L (UNII: 3OWL53L36 A) MENTHO L (UNII: L7T10 EIP3A) PRODUCT CHARACTERISTICS COLOR white S CORE no sco re Lucella Co.,ltd COLOR S CORE S HAP E ROUND S IZ E 12mm FLAVOR PEPPERMINT IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPT Soma hati kamili