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NDC 66467-2260-01 60 Second Fluoride Gel 5.6 g/454g Details

60 Second Fluoride Gel 5.6 g/454g

60 Second Fluoride Gel is a DENTAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Darby Dental Supply, LLC. 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: 66467-2260-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fluoride

Product Information

NDC	66467-2260
Product ID	66467-2260_d65adc81-ac53-de4b-e053-2a95a90a0609
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	60 Second Fluoride Gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Sodium Fluoride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GEL
Route	DENTAL
Active Ingredient Strength	5.6
Active Ingredient Units	g/454g
Substance Name	SODIUM FLUORIDE
Labeler Name	Darby Dental Supply, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 66467-2260-01 (66467226001)

Pricing Information	N/A
NDC Package Code	66467-2260-1
Billing NDC	66467226001
Package	454 g in 1 BOTTLE, PLASTIC (66467-2260-1)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 90a3cb10-c205-278d-e053-2a95a90a848e Details

Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Fluoride Treatment Gel

Indications and Usage:

A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Use Only. This product is not intended for home or unsupervised use.

Warnings:

Keep out of reach of children.
Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
Read directions carefully before using.

Dosage and Administration:

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

Do not store 25°C/77°F. Do not freeze.

Inactive Ingredients:

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain Blue #1, Green #3, Red #3, Red #40, Yellow #5 (tartazine). Yellow #6 as a color additive.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

60 SECOND FLUORIDE GEL

sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:66467-2260
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	5.6 g in 454 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66467-2260-1	454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/01/2019

Labeler - Darby Dental Supply, LLC (825137818)

Revised: 1/2022

Document Id: d65adc81-ac53-de4b-e053-2a95a90a0609

Set id: 90a3cb10-c205-278d-e053-2a95a90a848e

Version: 3

Effective Time: 20220124