AMERFRESH- sodium fluoride paste

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Sodium fluoride-0.22%
Available from:
SUHAN AEROSOL
Administration route:
DENTAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Anticavity Toothpaste. aids in the prevention of dental cavities
Authorization status:
unapproved drug other
Authorization number:
73398-114-01

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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.

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AMERFRESH FLUORIDE TOOTHPASTE

Active Ingredients

Sodium fluoride-0.22%

Purpos e

Anticavity Toothpaste.

Us es

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

AMERFRESH

SUHAN AEROSOL

sodium fluoride paste

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:7339 8 -114

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

2.2 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED (UNII: K6 79 OBS311)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

METHYLPARABEN SO DIUM (UNII: CR6 K9 C2NHK)

PRO PYLPARABEN SO DIUM (UNII: 6 25NNB0 G9 N)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7339 8 -114-0 1

7.1 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

12/0 1/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

12/0 1/20 20

Labeler -

SUHAN AEROSOL (861140760)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SUHAN AEROSOL

8 6 1140 76 0

ma nufa c ture (7339 8 -114)

Revised: 12/2020

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