AMERFRESH- sodium fluoride paste

AMERFRESH by

Drug Labeling and Warnings

AMERFRESH by is a Prescription medication manufactured, distributed, or labeled by SUHAN AEROSOL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

AMERFRESH 
sodium fluoride paste

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 73398-114
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73398-114-01	7.1 g in 1 POUCH; Type 0: Not a Combination Product	12/01/2020

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	Business Operations
SUHAN AEROSOL		861140760	manufacture(73398-114)