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AmerFresh

Amercare Products, Inc.

AmerFresh Fluoride Gel Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

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

PRINCIPAL DISPLAY PANEL - 85g Tube Label

AMERFRESH ®

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

AmerFresh

AmerFresh

Sodium Fluoride GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51460-1111
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.187 g

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
HYDRATED SILICA
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:51460-1111-1 85 in 1 TUBE
2 NDC:51460-1111-2 7.1 in 1 PACKET
3 NDC:51460-1111-3 17 in 1 TUBE
4 NDC:51460-1111-4 24 in 1 TUBE
5 NDC:51460-1111-5 43 in 1 TUBE
6 NDC:51460-1111-6 130 in 1 TUBE
7 NDC:51460-1111-7 181 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2012-11-14


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Be sure to consult your doctor before taking any medication!
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