60 SECOND FLUORIDE GEL- sodium fluoride gel

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

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Darby Dental Supply, LLC
Administration route:
DENTAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Fluoride Treatment Gel - 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.
Authorization status:
unapproved drug other
Authorization number:
66467-2250-1

60 SECOND FLUORIDE GEL- sodium fluoride gel

Darby Dental Supply, LLC

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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Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpos e:

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.

60 SECOND FLUORIDE GEL

sodium fluoride gel

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 6 46 7-2250

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

5.6 g in 454 g

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Darby Dental Supply, LLC

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

WATER (UNII: 0 59 QF0 KO0 R)

XANTHAN GUM (UNII: TTV12P4NEE)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

purple

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 6 46 7-2250 -

454 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /0 1/20 19

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

0 8 /0 1/20 19

Labeler -

Darby Dental Supply, LLC (825137818)

Revised: 8/2019

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