DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Διαθέσιμο από:

Darby Dental Supply, LLC

Οδός χορήγησης:

DENTAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Darby 9521534 Cherry 60 Second Fluoride Gel 2.72% Topical Sodium Fluoride Gel 1.23% fluoride ions 16.23 fl oz (480 ml) NDC 66467-2140-1

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

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._
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9521534 CHERRY
DARBY 60 SECOND FLUORIDE GEL 2.72 %
TOPICAL SODIUM FLUORIDE GEL
Darby 9521534 Cherry
60 Second Fluoride Gel
2.72% Topical Sodium Fluoride Gel
1.23% fluoride ions
16.23 fl oz (480 ml)
NDC 66467-2140-1
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, red 33,
saccharin sodium, titanium dioxide, cherry flavor
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 9521534
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 7-2140
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
pink
S CORE
S HAP E
S IZ E
FLAVOR
CHERRY
IMPRINT CODE
Darby Dental Supply, LLC
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:6 6 46