AMERFRESH FLUORIDE- sodium monofluorophosphate paste 
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 GelToothpaste

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a poison control center

Keep out of reach of children under 6 yrs. of age

Directions

Inactive Ingredients

SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

AmerFresh Fluoride Gel Toothpaste

image description

AMERFRESH FLUORIDE 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51460-3002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51460-3002-117 g in 1 TUBE; Type 0: Not a Combination Product09/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/12/2016
Labeler - Amercare Products, Inc. (879289254)
Registrant - Amercare Products, Inc. (879289254)

Revised: 9/2016
Document Id: 3c7a66a1-449c-460a-e054-00144ff8d46c
Set id: 43001122-cc78-48b8-9c10-7d2cfd6a9a2c
Version: 2
Effective Time: 20160914
 
Amercare Products, Inc.