AMERFRESH CLEAR- sodium fluoride paste, dentifrice

Amerfresh Clear by

Drug Labeling and Warnings

Amerfresh Clear 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

FLUORIDE gel TOOTHPASTE

DRUG FACTS

Active ingredient

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against 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 centre immediately.

Directions

• 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 physician.
• Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
• Children under 2 years: Ask a dentist or physician.

Inactive Ingredient

Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin, Treated water, SCMC, Sodium Lauryl Sulfate.

SPL UNCLASSIFIED SECTION

Exclusive Distributor: AMERCARE Products Inc. Seattle. WA 98165-2226.

PRINCIPAL DISPLAY PANEL - 181 g Carton Label

AMERFRESH®

FLUORIDE gel TOOTHPASTE

NET WT. 6.4 oz (181g)

INGREDIENTS AND APPEARANCE

AMERFRESH CLEAR 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51460-5010
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)	64 g  in 100 g
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
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	score with uneven pieces
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51460-5010-1	85 g in 1 TUBE
2	NDC: 51460-5010-2	42 g in 1 TUBE
3	NDC: 51460-5010-3	24 g in 1 TUBE
4	NDC: 51460-5010-4	17 g in 1 TUBE
5	NDC: 51460-5010-5	181 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/01/1996

Labeler - Amercare Products Inc (879289254)