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AmerFresh by Amercare Products, Inc.

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 1mg in 1g
Labeler: Amercare Products, Inc.
NDC Code: 51460-1112

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 toothpaste

Use

aids in the prevention of dental 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 Center immediately.

Directions
  • do not swallow
  • supervise children as necessary until capable of using 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 doctor.
  • Children under 6 years of age: Do not use unless directed by a doctor or dentist

Inactive ingredients

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

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112

AMERFRESH®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1114

AMERFRESH®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

AMERFRESH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (Fluoride Ion) Fluoride Ion1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate 
Water 
Sorbitol 
Hydrated Silica 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Saccharin Sodium 
Methylparaben Sodium 
Propylparaben Sodium 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51460-1112-185 g in 1 TUBE
2NDC:51460-1112-27.1 g in 1 PACKET
3NDC:51460-1112-31 TUBE in 1 BOX
385 g in 1 TUBE
4NDC:51460-1112-417 g in 1 TUBE
5NDC:51460-1112-524 g in 1 TUBE
6NDC:51460-1112-643 g in 1 TUBE
7NDC:51460-1112-71 TUBE in 1 BOX
743 g in 1 TUBE
8NDC:51460-1112-8130 g in 1 TUBE
9NDC:51460-1112-9181 g in 1 TUBE
10NDC:51460-1112-0142 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/14/2012
AMERFRESH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (Fluoride Ion) Fluoride Ion1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate 
Water 
Sorbitol 
Hydrated Silica 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Saccharin Sodium 
Methylparaben Sodium 
Propylparaben Sodium 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51460-1114-085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/14/2012
Labeler - Amercare Products, Inc. (879289254)

Revised: 01/2015
 
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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