AMERFRESH TOOTH- sodium fluoride powder
Yangzhou SION Commodity Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

For Use:

Wet toothbrush and dip into powder until brush is fully covered
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, silica,sodium lauryl sulfate, flavor, sodium sacharine, methylisothiazolinone

AMERFRESH TOOTH
sodium fluoride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70766-004
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
CALCIUM CARBONATE (UNII: H0G9379FGK)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70766-004-01	40 in 1 CARTON	04/20/2018
1		454 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:70766-004-02	4 in 1 CARTON	04/20/2018
2		50 in 1 BOX
2		57 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	04/20/2018

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou SION Commodity Co.,Ltd		546806042	manufacture(70766-004)