Search by Drug Name or NDC

NDC 00404-0118-04 Acclean plus 5 mg/g Details

Acclean plus 5 mg/g

Acclean plus is a ORAL GEL, DENTIFRICE 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: 00404-0118-04
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	00404-0118
Product ID	0404-0118_b9baee91-bbf9-32e0-e053-2a95a90a8717
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 plus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Flouride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL, DENTIFRICE
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/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 00404-0118-04 (00404011804)

Pricing Information	N/A
NDC Package Code	0404-0118-04
Billing NDC	00404011804
Package	113.4 g in 1 TUBE (0404-0118-04)
Marketing Start Date	2019-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 63b0de92-d0fb-4909-b3ae-145316ff4b51 Details

ACTIVE INGREDIENT:

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

INACTIVE INGREDIENTS:

Purified Water, Glycerin, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Xylitol, Sodium Benzoate, Titanium Dioxide,

Sylodent 756 (Silica), Casein, Microcrystalline Calcium Hydroxyapatite, Spearmint Oil, Peppermint Oil, Carboxymethyl Cellulose, Phosphoric Acid,

Sodium Hydroxide

DIRECTIONS:

Adults and children six years of age and older should brush with Acclean Plus Home Care Gel once at bedtime ( or as directed by physician or dentist). Apply a thin bead of gel to toothbrush and brush for at least one minute, making sure all tooth surfaces are covered.

ADULTS: Expectorate thoroughly. Do not rinse, drink or eat for at least 30 minutes after use.

CHILDREN SIX YEARS OF AGE AND OLDER: Expectorate and rinse thoroughly.

If recommended by your dental professional, this product can be used in place of your regular toothpaste. Read all instructions and prescribing information before using this product.

INDICATIONS:

Helps prevent dental caries and hypersensitivity.

WARNING:

DO NOT SWALLOW. To avoid ingestion, supervision is required while children are using this product.

Swallowing excessive amounts of fluoride could cause dental fluorosis.

KEEP OUT OF REACH OF CHILDREN AND INFANTS. This product should not be used by individuals with milk allergies.

PRECAUTIONS:

Federal (USA) Law prohibits dispensing without prescription. Store at controlled room temperature 68 - 77 F (20° C - 25° C).

Principal display panel

INGREDIENTS AND APPEARANCE

ACCLEAN PLUS

sodium flouride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0404-0118
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CASEIN (UNII: 48268V50D5)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0404-0118-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/30/2019

Labeler - Henry Schein (012430880)

Registrant - Henry Schein (012430880)

Revised: 1/2021

Document Id: b9baee91-bbf9-32e0-e053-2a95a90a8717

Set id: 63b0de92-d0fb-4909-b3ae-145316ff4b51

Version: 2

Effective Time: 20210125