AMERFRESH

AMERFRESH- sodium fluoride paste
SUHAN AEROSOL

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active Ingredients

Sodium fluoride-0.22%

Purpose

Anticavity Toothpaste.

Uses

aids in the prevention of dental cavities

Warnings

  • 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 right away.

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.
  • Do not swallow.
  • To minimize the swallowing ,use a pea-sized amount in children under 6 years old.
  • Supervise children’s brushing until good habits are established.
  • Children under 2 yrs : ask a dentist before use

Inactive Ingredients

Calcium Carbonate, Water,Sorbitol,Hydrated Silica, Sodium Lauryl Sulphate,Sodium Carboxymethyl cellulose, Flavor, Sodium Saccharin, Sodium methyl paraben, Sodium propyl paraben.

Product label

image description
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AMERFRESH
sodium fluoride paste
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73398-114
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
WATER
SORBITOL
HYDRATED SILICA
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SACCHARIN SODIUM
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73398-114-01 7.1 g in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2020
Labeler — SUHAN AEROSOL (861140760)
Establishment
Name Address ID/FEI Operations
SUHAN AEROSOL 861140760 manufacture (73398-114)

Revised: 12/2020 SUHAN AEROSOL

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