AMERFRESH FLUORIDE- sodium fluoride paste, dentifrice
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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70766-009

Active ingredients

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Purpose

anticavity toothpaste

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, Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Hydroypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben

image description

AMERFRESH FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70766-009
Route of Administration	TOPICAL

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
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM CARBONATE (UNII: 45P3261C7T)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70766-009-01	144 in 1 BOX	02/28/2022
1		17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:70766-009-02	144 in 1 BOX	02/28/2022
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:70766-009-03	144 in 1 BOX	02/28/2022
3		43 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:70766-009-04	144 in 1 BOX	02/28/2022
4		78 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:70766-009-05	144 in 1 BOX	02/28/2022
5		85 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:70766-009-06	144 in 1 BOX	02/28/2022
6		142 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:70766-009-07	1000 in 1 BOX	02/28/2022
7		7 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	02/28/2022

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(70766-009)