NDC Code(s) : 58578-1234-1, 58578-1234-2
Packager : Rowpar Pharmaceuticals, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CloSYS Sodium Fluoride RINSE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58578-1234
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.05 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)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58578-1234-11 in 1 BOX 18/02/2016
1473 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:58578-1234-2100 mL in 1 BOTTLE Type 0: Not a Combination Product18/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M021 02/18/2016

LABELER - Rowpar Pharmaceuticals, Inc.(783704661)

PRINCIPAL DISPLAY PANEL

473ml Inner Label

473 mL Carton

100 ml Label