AMERFRESH- sodium monofluorophosphate paste, dentifrice 
Amercare Products, Inc.

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.

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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 - 85g Tube Label

AMERFRESH®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

PRINCIPAL DISPLAY PANEL - 85g Tube Label
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) Sodium Monofluorophosphate0.646 g  in 85 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 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 in 1 BOX
743 g in 1 TUBE
8NDC:51460-1112-8130 g in 1 TUBE
9NDC:51460-1112-9181 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: 11/2012
Document Id: fe9a8650-f79c-4881-b59a-1d66bd115b02
Set id: 018990a8-bcc7-43f9-928e-db937f5705bc
Version: 1
Effective Time: 20121107
 
Amercare Products, Inc.