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AmerFresh Fluoride by Amercare Products, Inc.

Medically reviewed on September 14, 2016

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 1g
Labeler: Amercare Products, Inc.
NDC Code: 51460-3001

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 Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a poison control center

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

Directions
  • Adults and children 2 yrs. and older: Brush teeth throughtly 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

SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

AmerFresh Fluoride Toothpaste

AMERFRESH FLUORIDE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-3001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.76 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
CARBOXYMETHYLCELLULOSE 
GLYCERIN 
ALUMINUM HYDROXIDE 
HYDRATED SILICA 
POTASSIUM SORBATE 
SODIUM LAURYL SULFATE 
SORBITAN MONOOLEATE 
SORBITOL 
TITANIUM DIOXIDE 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:51460-3001-17.1 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/12/2016
Labeler - Amercare Products, Inc. (879289254)
Registrant - Amercare Products, Inc. (879289254)

 
Amercare Products, Inc.

← See all AmerFresh Fluoride brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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