Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Rowpar Pharmaceuticals, Inc.
SODIUM FLUORIDE
FLUORIDE ION 0.05 g in 100 mL
ORAL
OTC DRUG
Anticavity Aids in the prevention of dental cavities
OTC monograph final
CLOSYS FLUORIDE RINSE- SODIUM FLUORIDE RINSE ROWPAR PHARMACEUTICALS, INC. ---------- CLŌSYS SILVER ANTICAVITY FLUORIDE RINSE DRUG FACTS ACTIVE INGREDIENT Sodium fluoride 0.05% (0.02% w/v fluoride ion) PURPOSE Anticavity USE: Aids in the prevention of dental cavities WARNING: KEEP OUT OF REACH OF CHILDREN. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS: ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER: Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · do not eat or drink for 30 minutes after rinsing • instruct children under 12 years of age in good rinsing habits (to minimize swallowing) · supervise children as necessary until capable of using without supervision · CHILDREN UNDER 6 YEARS OF AGE: consult a dentist or doctor. OTHER INFORMATION: Do not use if safety seal is broken or missing INACTIVE INGREDIENTS: water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose _QUESTIONS OR COMMENTS? CALL 1-800-643-3337_ ® ® PACKAGING 473ml Inner Label 473 mL Carton 100 ml Label CLOSYS FLUORIDE RINSE sodium fluoride rinse PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:58578-1234 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.05 g in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) CHLORINE DIOXIDE (UNII: 8061YMS4RM) SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PEPPERMINT (UNII: V95R5KMY2B) Rowpar Pharmaceuticals, Inc. SUCRALOSE (UNII: 96K6UQ3ZD4) PRODUCT CHARACTERISTICS COLOR SCORE SHAPE SIZE FLAVOR PEPPERMINT IMPRINT CODE CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE M Přečtěte si celý dokument