DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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:

Darby 9521530 Mint 60 Second Fluoride Gel 2.72% Topical Sodium Fluoride Gel 1.23% fluoride ions 16.23 fl oz (480 ml) NDC 66467-2160-1

Authorization status:

unapproved drug other

Summary of Product characteristics

DARBY TOPICAL SODIUM FLUORIDE- 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._
----------
9521530 MINT
DARBY 60 SECOND FLUORIDE GEL
2.72 % TOPICAL SODIUM FLUORIDE GEL MINT
Darby 9521530 Mint
60 Second Fluoride Gel
2.72% Topical Sodium Fluoride Gel
1.23% fluoride ions
16.23 fl oz (480 ml)
NDC 66467-2160-1
A topical anti-caries preparation. Optimized low pH for penetration.
Ideal thixotropic action.
Artificially flavored.
DIRECTIONS :
1. Following prophylaxis treatment, fill 1/3 of tray with gel
2. Insert tray in the patient's mouth, have patient bite down lightly
for 60 seconds
3. Remove tray and have patient expectorate excess
4. Advise patient not to eat, drink or rinse for 30 minutes after the
application
MEDICINAL INGREDIENTS:
Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
NON-MEDICINAL INGREDIENTS: Carboxy methyl cellulose, phosphoric acid,
purified water, saccharin
sodium, titanium dioxide, blue 1, yellow 5, peppermint oil, spearmint
oil
.
WARNINGS :
KEEP OUT OF REACH OF CHILDREN.
For professional use only. Do not swallow.
Not recommended for use by children under 18 months of age.
Store at room temperature. Do not expose to excessive heat over 104°F
(40°C).
Do not use if seal is broken.
Made in the USA
Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753
UPC 9521530
Rev.02
DARBY TOPICAL SODIUM FLUORIDE
sodium fluoride gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 6 46 7-216 0
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
0 .0 272 g in 1 mL
PRODUCT CHARACTERISTICS
COLOR
gre e n
S CORE
S HAP E
S IZ E
FLAVOR
MINT
IMPRINT CODE
Darby Dental Supply, LLC
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE