AMERFRESH- sodium monofluorophosphate paste, dentifrice

AmerFresh by

Drug Labeling and Warnings

AmerFresh by is a Otc medication manufactured, distributed, or labeled by Amercare Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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:

51460-1114

AMERFRESH®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

INGREDIENTS AND APPEARANCE

AMERFRESH 
sodium monofluorophosphate paste, dentifrice

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Amercare Products, Inc. (879289254)