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Amerfresh

Amercare Products Inc

AMERFRESH


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

FLUORIDE TOOTHPASTE

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 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 Ingredients

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

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

PRINCIPAL DISPLAY PANEL - 141 g Carton Label

AMERFRESH®

FLUORIDE TOOTHPASTE

NET WT. 5 oz (141g)

Amerfresh

Amerfresh

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51460-5000
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
water
sorbitol
SILICON DIOXIDE
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
saccharin sodium
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51460-5000-1 141 in 1 TUBE
2 NDC:51460-5000-2 85 in 1 TUBE
3 NDC:51460-5000-3 42 in 1 TUBE
4 NDC:51460-5000-4 24 in 1 TUBE
5 NDC:51460-5000-5 17 in 1 TUBE
6 NDC:51460-5000-6 4.24 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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