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Amerfresh

Amercare Products Inc

AMERFRESH FLUORIDE TOOTHPOWDER


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active Ingredient

Sodium monofluorophosphate 0.76% (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 center 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 Ingredients

Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S.

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

PRINCIPAL DISPLAY PANEL - 446 g Carton

AMERFRESH ®
FLUORIDE TOOTHPOWDER

NET WEIGHT 1 lb (446 g)

Amerfresh

Amerfresh

Sodium Monofluorophosphate POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51460-0502
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 0.76 g

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
CARBOXYMETHYLCELLULOSE SODIUM
saccharin sodium
SODIUM LAURYL SULFATE
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
SILICON DIOXIDE
Ponceau 4R

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51460-0502-1 446 in 1 POUCH
2 NDC:51460-0502-2 57 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 1996-01-01


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Be sure to consult your doctor before taking any medication!
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