AMERFRESH- sodium fluoride paste 
Yangzhou SION Commodity Co.,Ltd

----------

Amerfresh Fluoride Toothpaste

Active ingredients

sodium fluoride 0.22%(0.1% w/v fluoride ion)

Purpose

anticavity

Uses

aids in the prevention of dental cavities.

Warnings

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

Keep out of reach of children.

Directions

do not swallow .

supervise children as necessary until capable of useing without supervision

instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing).

Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.

Children under 6 years of age:do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT

sorbitol,polyethylene glycol,sodium carboxymethyl cellulose ,xanthan gum,hydrated silica,glycerin,sacchairn sodium,sodium lauryl sulfate,water,methylisothiazolinone

1

AMERFRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70766-002-01144 in 1 BOX05/25/2016
117 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70766-002-02144 in 1 BOX05/25/2016
224 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:70766-002-03144 in 1 BOX05/25/2016
343 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:70766-002-04144 in 1 BOX05/25/2016
478 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:70766-002-05144 in 1 BOX06/18/2016
585 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:70766-002-06144 in 1 BOX06/18/2016
6142 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:70766-002-071000 in 1 BOX06/18/2016
77 g in 1 BAG; Type 0: Not a Combination Product
8NDC:70766-002-101000 in 1 BOX06/18/2016
87.1 g in 1 BAG; Type 0: Not a Combination Product
9NDC:70766-002-085 in 1 CARTON11/29/2016
9144 in 1 BOX
917 g in 1 TUBE; Type 0: Not a Combination Product
10NDC:70766-002-095 in 1 CARTON11/29/2016
10144 in 1 BOX
1024 g in 1 TUBE; Type 0: Not a Combination Product
11NDC:70766-002-1172 in 1 BOX06/18/2016
11142 g in 1 TUBE; Type 0: Not a Combination Product
12NDC:70766-002-1272 in 1 BOX06/18/2016
12181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02103/01/2016
Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-002)

Revised: 12/2023
Document Id: 0bf9dc10-06e0-0ebc-e063-6294a90a734a
Set id: 3f735eed-d9e6-2720-e054-00144ff88e88
Version: 10
Effective Time: 20231208
 
Yangzhou SION Commodity Co.,Ltd