Country: United States
Language: English
Source: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
SUNGWON PHARMACEUTICAL CO., LTD.
ORAL
OTC DRUG
■ Keeps teeth white and strong ■ Keep the oral cavity clean ■ Prevents tooth decay and bad breath caused by fluoride ■ Removing plaque, preventing gingivitis and periodontitis ■ Periodontal Disease Prevention ■ Gum Disease Prevention for oral use only
OTC monograph final
DR.NOAH SOLIDTOOTHPASTE- SODIUM FLUORIDE TABLET SUNGWON PHARMACEUTICAL 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 Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride INACTIVE INGREDIENT D-Sorbitol,Microcrystalline Cellulose, Xylitol, Enzymatically Modified Stevia, Bamboo Salt, L-Menthol, CombinedFlavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Combined Flavor(SperamintFlavor Powder), Yuzu Extract, Chamomile Powder, Sodium Bicarbonate, Xanthan Gum,Hydroxypropylcellulose, Magnesium Stearate, Sodium Cocoyl Glutamate PURPOSE ■ Keeps teeth white and strong ■ Keep the oral cavity clean ■ Prevents tooth decay and bad breath caused by fluoride ■ Removing plaque, preventing gingivitis and periodontitis ■ Periodontal Disease Prevention ■ Gum Disease Prevention KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. WARNING For oral use only When using this product ■ This toothpaste has a 1,000 ppm fluoride content ■ Do not use other than brushing teeth and be careful not to swallow Keep out of reach of children ■ if swallowed, seek medical help or contact the poison control center immediately USES for oral use only INDICATION & USAGE SECTION adults and children above the age of 6: chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as recommended by your doctor or dentist do not swallow the tablet DR.NOAH SOLIDTOOTHPASTE sodium fluoride tablet PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:76058-003 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH SODIUM BICARBONATE (UNII: 8MDF5V39QO) SORBITOL (U Read the complete document