AMERFRESH- sodium monofluorophosphate 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 Toothpaste

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

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, water, sorbitol, 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 - 85 g Tube Label - NDC 51460-1112

AMERFRESH®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112

PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1114

AMERFRESH®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1113

AMERFRESH
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51460-1112
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Calcium Carbonate (UNII: H0G9379FGK)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51460-1112-1	85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51460-1112-2	7.1 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC:51460-1112-3	1 in 1 BOX
3		85 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:51460-1112-4	17 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:51460-1112-5	24 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:51460-1112-6	43 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:51460-1112-7	1 in 1 BOX
7		43 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:51460-1112-8	130 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:51460-1112-9	181 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC:51460-1112-0	142 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	11/14/2012

AMERFRESH
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51460-1114
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Calcium Carbonate (UNII: H0G9379FGK)
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51460-1114-0	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	11/14/2012

Labeler - Amercare Products, Inc. (879289254)

Revised: 1/2015

Document Id: 26239955-403c-4dcd-9e8e-0b36d44a7e01

Set id: 018990a8-bcc7-43f9-928e-db937f5705bc

Version: 3

Effective Time: 20150115

Amercare Products, Inc.