Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Buzz Products (HK) Co. Limited
SODIUM FLUORIDE
FLUORIDE ION 1.6 mg in 1 g
OTC DRUG
helps protect against cavities
OTC monograph final
INTERNATIONAL BUSINESS CLASS 2 KIT- SODIUM FLUORIDE BUZZ PRODUCTS (HK) CO. LIMITED _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._ ---------- INTERNATIONAL BUSINESS CLASS #2 KIT _DRUG FACTS_ _ACTIVE INGREDIENT_ Sodium fluoride 0.243% _PURPOSE_ Anticavity toothpaste _USE_ helps protect against cavities _WARNING_ KEEP OUT OF 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. _DIRECTIONS_ adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist _INACTIVE INGREDIENTS_ glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M or PEG-23M, xanthan gum, sucralose, mica, titanium dioxide _QUESTIONS?_ 1-800-492-7378 PACKAGE LABELING INTERNATIONAL BUSINESS CLASS 2 KIT sodium fluoride kit PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70402-014 PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70402-014- 01 1 in 1 KIT; Type 0: Not a Combination Product 04/30/2018 12/31/2021 QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PART 1 1 TUBE 24 g PART 1 OF 1 CREST 3D WHITE BRILLIANCE sodium fluoride paste, dentifrice PRODUCT INFORMATION ITEM CODE (SOURCE) NDC:37000-873 ROUTE OF ADMINISTRATION DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.6 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH GLYCERI Прочитать полный документ