AMERFRESH CLEAR- sodium fluoride 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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AMERFRESH®

FLUORIDE gel TOOTHPASTE

DRUG FACTS

Active ingredient

Sodium Fluoride 0.22% (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 centre 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 Ingredient

Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin, Treated water, SCMC, Sodium Lauryl Sulfate.

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

PRINCIPAL DISPLAY PANEL - 181 g Carton Label

AMERFRESH®

FLUORIDE gel TOOTHPASTE

NET WT. 6.4 oz (181g)

PRINCIPAL DISPLAY PANEL - 181 g Carton Label
AMERFRESH CLEAR 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-5010
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R) 64 g  in 100 g
Water (UNII: 059QF0KO0R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Methylparaben Sodium (UNII: CR6K9C2NHK)  
Propylparaben Sodium (UNII: 625NNB0G9N)  
Product Characteristics
ColorWHITEScorescore with uneven pieces
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51460-5010-185 g in 1 TUBE
2NDC:51460-5010-242 g in 1 TUBE
3NDC:51460-5010-324 g in 1 TUBE
4NDC:51460-5010-417 g in 1 TUBE
5NDC:51460-5010-5181 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/1996
Labeler - Amercare Products Inc (879289254)

Revised: 3/2011
Document Id: 27b8a829-d438-439c-b6f5-710cb8e2de7a
Set id: bed07ba9-14ed-4dda-9bd9-49dfc5c12129
Version: 1
Effective Time: 20110316
 
Amercare Products Inc