AMERFRESH- sodium fluoride paste

Amerfresh by

Drug Labeling and Warnings

Amerfresh by is a Otc medication manufactured, distributed, or labeled by Yangzhou SION Commodity Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMERFRESH 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70766-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 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
1	NDC: 70766-002-01	144 in 1 BOX	05/25/2016
1		17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70766-002-02	144 in 1 BOX	05/25/2016
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 70766-002-03	144 in 1 BOX	05/25/2016
3		43 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 70766-002-04	144 in 1 BOX	05/25/2016
4		78 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 70766-002-05	144 in 1 BOX	06/18/2016
5		85 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 70766-002-06	144 in 1 BOX	06/18/2016
6		142 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 70766-002-07	1000 in 1 BOX	06/18/2016
7		7 g in 1 BAG; Type 0: Not a Combination Product
8	NDC: 70766-002-10	1000 in 1 BOX	06/18/2016
8		7.1 g in 1 BAG; Type 0: Not a Combination Product
9	NDC: 70766-002-08	5 in 1 CARTON	11/29/2016
9		144 in 1 BOX
9		17 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 70766-002-09	5 in 1 CARTON	11/29/2016
10		144 in 1 BOX
10		24 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC: 70766-002-11	72 in 1 BOX	06/18/2016
11		142 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC: 70766-002-12	72 in 1 BOX	06/18/2016
12		181 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 not final	part356	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)