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Amerfresh Fluoride by Yangzhou Holyshine Industrial Co. Ltd

Medically reviewed on October 12, 2016

Dosage form: paste
Ingredients: SODIUM FLUORIDE 2.2mg in 1g
Labeler: Yangzhou Holyshine Industrial Co. Ltd
NDC Code: 60931-303

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

Drug Facts

Active Ingredient

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

Purpose

Anticavity toothpaste

Use

aids prevention of dental cavities

Warnings

Keep out of reach of children under 6 yrs. of age

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 2 yrs. and older:  Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
  • Do not swallow
  • To minimize swallowing, use a pea-sized amount in children under 6 years old
  • Supervise children's brushing until good habits are established
  • Children under 2 yrs:  ask a dentist before use

Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl paraben.

Package Labeling:

AMERFRESH FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60931-303
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SACCHARIN SODIUM 
METHYLPARABEN SODIUM 
PROPYLPARABEN SODIUM 
Packaging
#Item CodePackage Description
1NDC:60931-303-017.1 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/12/2016
Labeler - Yangzhou Holyshine Industrial Co. Ltd (421141948)

 
Yangzhou Holyshine Industrial Co. Ltd

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Further information

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

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