NDC Code(s) : 70766-002-01, 70766-002-02, 70766-002-03, 70766-002-04, 70766-002-05, 70766-002-06, 70766-002-07, 70766-002-10, 70766-002-08, 70766-002-09, 70766-002-11, 70766-002-12
Packager : Yangzhou SION Commodity Co.,Ltd

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AmerfreshSodium Fluoride PASTE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-002
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.22 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
DISODIUM CARBOXYMETHYLARSONATE(UNII: T9HTL93NB7)
SORBITOL(UNII: 506T60A25R)
XANTHAN GUM(UNII: TTV12P4NEE)
METHYLENE GLYCOL(UNII: 6Z20YM9257)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70766-002-01144 in 1 BOX 25/05/2016
117 g in 1 TUBE Type 0: Not a Combination Product
2NDC:70766-002-02144 in 1 BOX 25/05/2016
224 g in 1 TUBE Type 0: Not a Combination Product
3NDC:70766-002-03144 in 1 BOX 25/05/2016
343 g in 1 TUBE Type 0: Not a Combination Product
4NDC:70766-002-04144 in 1 BOX 25/05/2016
478 g in 1 TUBE Type 0: Not a Combination Product
5NDC:70766-002-05144 in 1 BOX 18/06/2016
585 g in 1 TUBE Type 0: Not a Combination Product
6NDC:70766-002-06144 in 1 BOX 18/06/2016
6142 g in 1 TUBE Type 0: Not a Combination Product
7NDC:70766-002-071000 in 1 BOX 18/06/2016
77 g in 1 BAG Type 0: Not a Combination Product
8NDC:70766-002-101000 in 1 BOX 18/06/2016
87.1 g in 1 BAG Type 0: Not a Combination Product
9NDC:70766-002-085 in 1 CARTON 29/11/2016
9144 in 1 BOX 18/06/2016
917 g in 1 TUBE Type 0: Not a Combination Product
10NDC:70766-002-095 in 1 CARTON 29/11/2016
10144 in 1 BOX 18/06/2016
1024 g in 1 TUBE Type 0: Not a Combination Product
11NDC:70766-002-1172 in 1 BOX 18/06/2016
11142 g in 1 TUBE Type 0: Not a Combination Product
12NDC:70766-002-1272 in 1 BOX 18/06/2016
12181 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 03/01/2016

LABELER - Yangzhou SION Commodity Co.,Ltd(546806042)

REGISTRANT - Yangzhou SION Commodity Co.,Ltd(546806042)

Establishment
Name Address ID/FEI Business Operations
Yangzhou SION Commodity Co.,Ltd 546806042 manufacture(70766-002)

PRINCIPAL DISPLAY PANEL

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