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

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70766-001 Amerfresh Fluoride Toothpaste

Active ingredients

Sodium monofluorophosphate 0.76%(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

calcium carbonate,water,sorbitol,hydrated silica,sodium lauryl sulfate,sodium carboxymethyl cellulose,flavor,sodium sacharine,polymethylene glycol,guar gum,methylisothiazolinone.

a

AMERFRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70766-001-01144 in 1 BOX05/25/2016
117 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70766-001-02144 in 1 BOX05/25/2016
224 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:70766-001-03144 in 1 BOX05/25/2016
343 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:70766-001-04144 in 1 BOX05/25/2016
478 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:70766-001-05144 in 1 BOX06/18/2016
585 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:70766-001-06144 in 1 BOX06/18/2016
6142 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:70766-001-071000 in 1 BOX06/18/2016
77 g in 1 BAG; 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(70766-001)

Revised: 12/2023
Document Id: 0bf9a782-c0dc-85bf-e063-6294a90af815
Set id: 35df5050-2215-4b1d-e054-00144ff8d46c
Version: 5
Effective Time: 20231208
 
Yangzhou SION Commodity Co.,Ltd