Country: United States
Language: English
Source: NLM (National Library of Medicine)
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)
Zeniton Co.,Ltd.
DENTAL
OTC DRUG
Anticavity ■ Helps protect against cavities ■ Removal of plaque
OTC monograph final
DR. ZENNI GUM PROJECT PROPOLI TOOTH FOR GUM DISEASE- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE ZENITON 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 Sodium Monofluorophosphate 0.75% PURPOSE Anticavity KEEP OUT OF REACH OF CHILDREN Keep out of reach of children USES ■ Helps protect against cavities ■ Removal of plaque WARNINGS Keep out or reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. INACTIVE INGREDIENTS D-Sorbitol Solution, Silicon Dioxide, Water, Concentrated Glycerin, Propolis Extract, Sodium Chloride, Sodium Cocoyl Glutamate, Xanthangum, Peppermint Oil, Aminocaproic Acid, Aluminum Chlorohydroxy Allantoinate, Grapefruit Seed Extract, Xylitol, Tocopherol Acetate, Calendula Extract, Eucalyptus Extract, Green Tea Extract, Sage Extract, Aloe Extract, Mastic Oil, Myrrh, Chitosan DIRECTIONS ■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. ■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. ■ Children under 2 years: Consult a dentist or doctor. OTHER INFORMATION ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light (1~30℃) QUESTIONS ■ www.zeniton.com PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Zeniton Co.,Ltd. DR. ZENNI GUM PROJECT PROPOLI TOOTH FOR GUM DISEASE sodium monofluorophosphate paste, dentifrice PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:73029-0006 ROUTE OF ADMINISTRATION DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION Read the complete document