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AmerFresh by Amercare Products, Inc.

Medically reviewed on November 7, 2017

Dosage form: gel, dentifrice
Ingredients: Sodium Fluoride 0.187g in 85g
Labeler: Amercare Products, Inc.
NDC Code: 51460-1111

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 Gel Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.22% (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 2 years of age: Consult a dentist or doctor

Inactive ingredients

sorbitol, water, 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 - 85g Tube Label

AMERFRESH®

FLUORIDE Gel TOOTHPASTE
NET WT. 3 oz (85g)

AMERFRESH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride0.187 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Water 
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:51460-1111-185 g in 1 TUBE
2NDC:51460-1111-27.1 g in 1 PACKET
3NDC:51460-1111-317 g in 1 TUBE
4NDC:51460-1111-424 g in 1 TUBE
5NDC:51460-1111-543 g in 1 TUBE
6NDC:51460-1111-6130 g in 1 TUBE
7NDC:51460-1111-7181 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)

 
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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