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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 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 For Use

  • wet toothbrush and dip into powder until brush is fully covered
  • brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly
  • 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, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S.

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

PRINCIPAL DISPLAY PANEL - 57 g Packet Label

AMERFRESH ®
FLUORIDE TOOTHPOWDER

NET WT. 2 oz (57g)

AmerFresh

AmerFresh

Sodium Monofluorophosphate POWDER, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51460-1113
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 0.4332 g

Inactive Ingredients

Ingredient Name Strength
CALCIUM CARBONATE
CARBOXYMETHYLCELLULOSE SODIUM
saccharin sodium
SODIUM LAURYL SULFATE
HYDRATED SILICA
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51460-1113-1 57 in 1 PACKET
2 NDC:51460-1113-2 446 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-12-20


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