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Amerfresh by Amercare Products Inc

Medically reviewed on March 16, 2018

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 0.76g in 100g
Labeler: Amercare Products Inc
NDC Code: 51460-5000

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

DRUG FACTS

Active ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities.

Warning

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 centre immediately.

Directions
Adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
Children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 yearsAsk a dentist or physician.

Inactive Ingredients

Sorbitol, Silica, Calcium Carbonate, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.

Exclusive Distributor: AMERCARE Products Inc. Seattle. WA 98165-2226.

PRINCIPAL DISPLAY PANEL - 141 g Carton Label

AMERFRESH®

FLUORIDE TOOTHPASTE

NET WT. 5 oz (141g)

AMERFRESH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-5000
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (Fluoride Ion) Sodium Monofluorophosphate0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate42 g  in 100 g
Water 
Sorbitol 
Silicon Dioxide 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Saccharin Sodium 
Methylparaben Sodium 
Propylparaben Sodium 
Product Characteristics
ColorWHITEScorescore with uneven pieces
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51460-5000-1141 g in 1 TUBE
2NDC:51460-5000-285 g in 1 TUBE
3NDC:51460-5000-342 g in 1 TUBE
4NDC:51460-5000-424 g in 1 TUBE
5NDC:51460-5000-517 g in 1 TUBE
6NDC:51460-5000-64.24 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/1996
Labeler - Amercare Products Inc (879289254)

 
Amercare Products Inc

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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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