NDC Code(s) : 58578-0749-1, 58578-0749-2, 58578-0749-3
Packager : Rowpar Pharmaceuticals, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CloSYSSodium Fluoride PASTE, DENTIFRICE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58578-0749
Route of Administration ORAL, DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SUCRALOSE(UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
CHLORINE DIOXIDE(UNII: 8061YMS4RM)
PEPPERMINT OIL(UNII: AV092KU4JH)
MENTHOL(UNII: L7T10EIP3A)
SODIUM LAUROYL SARCOSINATE(UNII: 632GS99618)
Product Characteristics
Color white Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58578-0749-11 in 1 BOX 20/10/2017
196 g in 1 TUBE Type 0: Not a Combination Product
2NDC:58578-0749-21 in 1 BOX 20/10/2017
2198 g in 1 TUBE Type 0: Not a Combination Product
3NDC:58578-0749-31 in 1 BOX 20/10/2017
321 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M021 10/20/2017

LABELER - Rowpar Pharmaceuticals, Inc.(783704661)

Establishment
Name Address ID/FEI Business Operations
Transom Symphony OPCO, LLC 117501991 manufacture(58578-0749)

PRINCIPAL DISPLAY PANEL

Closys®
Anticavity Fluoride Toothpaste

SULFATE-FREE

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS ®
Anticavity Fluoride Toothpaste

SENSITIVE
TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING
SULFATE-FREE

HELPS REBUILD WEAKEND
TOOTH ENAMEL

Protects Against
Cavities

Freshens Breath

Non-Irritating
Formula

Gentle Mint

7oz (196g)

NON-IRRITATING
SULFATE-FREE

pH balanced

Fights
Cavities

Strengthens
Enamel

Closys®
Anticavity Fluoride Toothpaste

SENSITIVE TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING SULFATE-FREE

HELPS REBUILD WEAKEND TOOTH ENAMEL

Protects Against Cavities

Freshens Breath

Non-Irritating Formula

Gentle Mint 7oz (196g)

Closys®
Anticavity Fluoride Toothpaste

SULFATE-FREE

NEW LOOK!

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS ®
Anticavity Fluoride Toothpaste

SENSITIVE
TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING
SULFATE-FREE

HELPS REBUILD WEAKEND
TOOTH ENAMEL

Protects Against
Cavities

Freshens Breath

Non-Irritating
Formula

Gentle Mint

3.4oz (96g)

NON-IRRITATING
SULFATE-FREE

pH balanced

Fights
Cavities

Strengthens
Enamel

Closys®
Anticavity Fluoride Toothpaste

SENSITIVE TOOTHPASTE
WITH FLUORIDE

NON-IRRITATING SULFATE-FREE

HELPS REBUILD WEAKEND TOOTH ENAMEL

Protects Against Cavities

Freshens Breath

Non-Irritating Formula

Gentle Mint 3.4oz (96g)