NDC Code(s) : 70766-001-01, 70766-001-02, 70766-001-03, 70766-001-04, 70766-001-05, 70766-001-06, 70766-001-07
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:70766-001
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE(UNII: C810JCZ56Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.76 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GUAR GUM(UNII: E89I1637KE)
POTASSIUM SODIUM SACCHARATE(UNII: 73U34YC90U)
CALCIUM CARBONATE(UNII: H0G9379FGK)
SORBITOL(UNII: 506T60A25R)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
METHYLENE GLYCOL(UNII: 6Z20YM9257)
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DISODIUM CARBOXYMETHYLARSONATE(UNII: T9HTL93NB7)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70766-001-01144 in 1 BOX 25/05/2016
117 g in 1 TUBE Type 0: Not a Combination Product
2NDC:70766-001-02144 in 1 BOX 25/05/2016
224 g in 1 TUBE Type 0: Not a Combination Product
3NDC:70766-001-03144 in 1 BOX 25/05/2016
343 g in 1 TUBE Type 0: Not a Combination Product
4NDC:70766-001-04144 in 1 BOX 25/05/2016
478 g in 1 TUBE Type 0: Not a Combination Product
5NDC:70766-001-05144 in 1 BOX 18/06/2016
585 g in 1 TUBE Type 0: Not a Combination Product
6NDC:70766-001-06144 in 1 BOX 18/06/2016
6142 g in 1 TUBE Type 0: Not a Combination Product
7NDC:70766-001-071000 in 1 BOX 18/06/2016
77 g in 1 BAG 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(70766-001)

PRINCIPAL DISPLAY PANEL

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