AMERFRESH- sodium fluoride gel, 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 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

Inactive ingredients

sorbitol, water, 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 Gel TOOTHPASTE
NET WT. 3 oz (85g)

PRINCIPAL DISPLAY PANEL - 85g Tube Label
AMERFRESH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-1111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.187 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Methylparaben Sodium (UNII: CR6K9C2NHK)  
Propylparaben Sodium (UNII: 625NNB0G9N)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51460-1111-185 g in 1 TUBE
2NDC:51460-1111-27.1 g in 1 PACKET
3NDC:51460-1111-317 g in 1 TUBE
4NDC:51460-1111-424 g in 1 TUBE
5NDC:51460-1111-543 g in 1 TUBE
6NDC:51460-1111-6130 g in 1 TUBE
7NDC:51460-1111-7181 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: f4796a85-7502-4122-92d5-4c8af32d3273
Set id: 7d12eab2-ad71-4743-9c47-2f3b3bc2aa81
Version: 1
Effective Time: 20121107
 
Amercare Products, Inc.