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Amerfresh by Yangzhou SION Commodity Co.,Ltd

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.22g in 100g
Labeler: Yangzhou SION Commodity Co.,Ltd
NDC Code: 70766-002

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.

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

AMERFRESH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-002
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
METHYLISOTHIAZOLINONE 
POLYETHYLENE GLYCOLS 
DISODIUM CARBOXYMETHYLARSONATE 
SORBITOL 
XANTHAN GUM 
METHYLENE GLYCOL 
WATER 
GLYCERIN 
SODIUM LAURYL SULFATE 
HYDRATED SILICA 
Packaging
#Item CodePackage Description
1NDC:70766-002-01144 TUBE in 1 BOX
117 g in 1 TUBE
2NDC:70766-002-02144 TUBE in 1 BOX
224 g in 1 TUBE
3NDC:70766-002-03144 TUBE in 1 BOX
343 g in 1 TUBE
4NDC:70766-002-04144 TUBE in 1 BOX
478 g in 1 TUBE
5NDC:70766-002-05144 TUBE in 1 BOX
585 g in 1 TUBE
6NDC:70766-002-06144 TUBE in 1 BOX
6142 g in 1 TUBE
7NDC:70766-002-071000 BAG in 1 BOX
77 g in 1 BAG
8NDC:70766-002-101000 BAG in 1 BOX
87.1 g in 1 BAG
9NDC:70766-002-085 BOX in 1 CARTON
9144 TUBE in 1 BOX
917 g in 1 TUBE
10NDC:70766-002-095 BOX in 1 CARTON
10144 TUBE in 1 BOX
1024 g in 1 TUBE
11NDC:70766-002-1172 TUBE in 1 BOX
11142 g in 1 TUBE
12NDC:70766-002-1272 TUBE in 1 BOX
12181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/01/2016
Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
Establishment
NameAddressID/FEIOperations
Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-002)

 
Yangzhou SION Commodity Co.,Ltd

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Medically reviewed on Oct 25, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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