AMERFRESH- sodium fluoride gel, 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 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

• 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 2 years of age: Consult a dentist or doctor

Inactive ingredients

sorbitol, water, 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 - 85g Tube Label

AMERFRESH®

FLUORIDE Gel TOOTHPASTE
NET WT. 3 oz (85g)

INGREDIENTS AND APPEARANCE

AMERFRESH 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51460-1111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	0.187 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51460-1111-1	85 g in 1 TUBE
2	NDC: 51460-1111-2	7.1 g in 1 PACKET
3	NDC: 51460-1111-3	17 g in 1 TUBE
4	NDC: 51460-1111-4	24 g in 1 TUBE
5	NDC: 51460-1111-5	43 g in 1 TUBE
6	NDC: 51460-1111-6	130 g in 1 TUBE
7	NDC: 51460-1111-7	181 g in 1 TUBE

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)