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NDC 00404-1741-44 Acclean Foam Fluoride 60 Second Application 0.0272 g/g Details

Acclean Foam Fluoride 60 Second Application 0.0272 g/g

Acclean Foam Fluoride 60 Second Application is a DENTAL AEROSOL, FOAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Henry Schein. The primary component is SODIUM FLUORIDE.

MedlinePlus Drug Summary

Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00404-1741-44
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	00404-1741
Product ID	0404-1741_c10af94e-1abe-7808-e053-2a95a90ae51d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Acclean Foam Fluoride 60 Second Application
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	AEROSOL, FOAM
Route	DENTAL
Active Ingredient Strength	0.0272
Active Ingredient Units	g/g
Substance Name	SODIUM FLUORIDE
Labeler Name	Henry Schein
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00404-1741-44 (00404174144)

Pricing Information	N/A
NDC Package Code	0404-1741-44
Billing NDC	00404174144
Package	125 g in 1 CANISTER (0404-1741-44)
Marketing Start Date	2021-04-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c10af938-0537-2425-e053-2a95a90ad608 Details

General Information

Henry Schein, Inc.

Acclean Foam Fluoride 60 Second Application

Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion)

Contains:

Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant.

Gluten free.

Indications

For topical application to aid in the protection against dental caries.

Warnings

Contens under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 50-80F. Keep from freezing. do not spray toward open flame.

Instructions For Use

Prior to each use, shake can thoroughly for at least 15 seconds.
To dispense, invert can completely upside down. Slowly depress nozzle to fill fluoride applicator tray (foam will expand slightly higher than fluoride tray).
Tooth surface must be dry prior to inserting tray(s) in mouth.
Insert tray(s) into mouth and have patient bite down for 1-4 minutes.
Remove tray(s) and have patient expectorate.
Advise patient not to eat, drink or rinse for 30 minutes after treatment.

Professional Use Only

Principal Display Panel

INGREDIENTS AND APPEARANCE

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION

sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1731
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1731-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION

sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1711
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
BETAINE (UNII: 3SCV180C9W)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1711-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION

sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1701
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1701-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION

sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1721
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1721-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

ACCLEAN FOAM FLUORIDE 60 SECOND APPLICATION

sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-1741
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLOXAMER 407 (UNII: TUF2IVW3M2)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BETAINE (UNII: 3SCV180C9W)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (Cream)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-1741-44	125 g in 1 CANISTER; Type 0: Not a Combination Product	04/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/28/2021

Labeler - Henry Schein (012430880)

Revised: 4/2021

Document Id: c10af94e-1abe-7808-e053-2a95a90ae51d

Set id: c10af938-0537-2425-e053-2a95a90ad608

Version: 1

Effective Time: 20210428

Search by Drug Name or NDC

NDC 00404-1741-44 Acclean Foam Fluoride 60 Second Application 0.0272 g/g Details

Acclean Foam Fluoride 60 Second Application 0.0272 g/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00404-1741-44 (00404174144)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c10af938-0537-2425-e053-2a95a90ad608 Details

General Information

Indications

Warnings

Instructions For Use

Principal Display Panel

Principal Display Panel

Principal Display Panel

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

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