DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Darby Dental Supply, LLC

Via di somministrazione:

DENTAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Darby 9521532 Bubble Gum 60 Second Fluoride Gel 2.72% Topical Sodium Fluoride Gel 1.23% fluoride ions 16.23 fl oz (480 ml) NDC 66467-2130-1

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

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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9521532 BUBBLE GUM
DARBY 60 SECOND FLUORIDE GEL 2.72 %
TOPICAL SODIUM FLUORIDE GEL
Darby 9521532 Bubble Gum
60 Second Fluoride Gel
2.72% Topical Sodium Fluoride Gel
1.23% fluoride ions
16.23 fl oz (480 ml)
NDC 66467-2130-1
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, bubble gum 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 9521532
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 7-2130
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
BUBBLE GUM
IMPRINT CODE
Darby Dental Supply, LLC
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
D