AMERFRESH- sodium monofluorophosphate powder 
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

Use

helps protect against 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

Adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician.
Children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 yearsAsk a Dentist or physician.

Inactive Ingredients

Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S.

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

PRINCIPAL DISPLAY PANEL - 446 g Carton

AMERFRESH®
FLUORIDE TOOTHPOWDER

NET WEIGHT 1 lb (446 g)

Principal Display Panel - 446 g Carton
AMERFRESH 
sodium monofluorophosphate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-0502
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Calcium Carbonate (UNII: H0G9379FGK) 94.98 g  in 100 g
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Methylparaben Sodium (UNII: CR6K9C2NHK)  
Propylparaben Sodium (UNII: 625NNB0G9N)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Ponceau 4R (UNII: Z525CBK9PG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51460-0502-1446 g in 1 POUCH
2NDC:51460-0502-257 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/1996
Labeler - Amercare Products Inc (879289254)

Revised: 5/2011
Document Id: 843e8d6b-8bb6-4c81-8089-8a500ebe6bd4
Set id: 1e09d9ed-b8e2-4998-845b-93ed861542be
Version: 1
Effective Time: 20110512
 
Amercare Products Inc