Your browser does not support JavaScript! AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) POWDER, DENTIFRICE [AMERCARE PRODUCTS, INC.]
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RxNorm Names

AMERFRESH (sodium monofluorophosphate) powder, dentifrice
[Amercare Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • wet toothbrush and dip into powder until brush is fully covered
  • brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly
  • 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, 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51460-1113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (Fluoride Ion) Fluoride Ion0.4332 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
calcium carbonate 
carboxymethylcellulose sodium 
saccharin sodium 
sodium lauryl sulfate 
hydrated silica 
methylparaben sodium 
propylparaben sodium 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51460-1113-157 g in 1 PACKET
2NDC:51460-1113-2446 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/20/2011
Labeler - Amercare Products, Inc. (879289254)

Revised: 1/2013
 
Amercare Products, Inc.

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