AMERFRESH- sodium monofluorophosphate powder, 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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AmerFresh®
Fluoride Toothpowder

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
For Use

Inactive ingredients

calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S.

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

PRINCIPAL DISPLAY PANEL - 57 g Packet Label

AMERFRESH®
FLUORIDE TOOTHPOWDER

NET WT. 2 oz (57g)

PRINCIPAL DISPLAY PANEL - 57 g Packet Label
AMERFRESH 
sodium monofluorophosphate powder, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51460-1113
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.4332 g  in 57 g
Inactive Ingredients
Ingredient Name Strength
calcium carbonate (UNII: H0G9379FGK)  
carboxymethylcellulose sodium (UNII: K679OBS311)  
saccharin sodium (UNII: SB8ZUX40TY)  
sodium lauryl sulfate (UNII: 368GB5141J)  
hydrated silica (UNII: Y6O7T4G8P9)  
methylparaben sodium (UNII: CR6K9C2NHK)  
propylparaben sodium (UNII: 625NNB0G9N)  
Product Characteristics
Color PINK Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51460-1113-1 57 g in 1 PACKET
2 NDC:51460-1113-2 446 g in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 12/20/2011
Labeler - Amercare Products, Inc. (879289254)

Revised: 1/2013
Document Id: c4e05d34-45f9-4883-9238-628b1562a55b
Set id: 02ae9422-6c06-4c91-ac42-de7368825e5b
Version: 1
Effective Time: 20130111
 
Amercare Products, Inc.