DARBY TOPICAL SODIUM FLUORIDE BUBBLE GUM- sodium fluoride aerosol, foam

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 9529104 Bubble Gum Topical Fluoride Foam 2.72% Topical Sodium Fluoride Foam 1.23% fluoride ions 4.4 oz (125 g) NDC 66467-3730-1

Authorization status:

unapproved drug other

Summary of Product characteristics

DARBY TOPICAL SODIUM FLUORIDE BUBBLE GUM- SODIUM FLUORIDE AEROSOL,
FOAM
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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9529104 BUBBLE GUM
DARBY TOPICAL FLUORIDE FOAM
2.72% TOPICAL SODIUM FLUORIDE FOAM
Darby 9529104 Bubble Gum
Topical Fluoride Foam
2.72% Topical Sodium Fluoride Foam
1.23% fluoride ions
4.4 oz (125 g)
NDC 66467-3730-1
A topical anti-caries preparation.
DIRECTIONS :
1. Following prophylaxis treatment, fill 1/4 of tray with foam
2. To dispense, shake bottle vigorously then invert applicator 180°
downward to the bottom of the tray
3. Insert tray, have patient bite down lightly for a minimum of 60
seconds, up to 4 minutes
4. Remove tray and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the
treatment
MEDICINAL INGREDIENTS:
Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
NON-MEDICINAL INGREDIENTS: Cocamidopropyl betaine, sodium phosphate
monobasic, poloxamer 407,
sucralose, xylitol, purified water, bubble gum flavor
WARNINGS :
KEEP OUT OF REACH OF CHILDREN
For professional use only. Avoid spraying toward open flame. Store at
room temperature. Do not
expose to excessive heat over 104°F (40°C). Contents under pressure.
Do not puncture and incinerate.
Do not use if seal is broken.
Made in the USA
Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753
UPC 9529104
Rev.02
DARBY TOPICAL SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foam
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 6 46 7-3730
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 g
Darby Dental Supply, LLC
PRODUCT CHARACTERISTICS
COLOR
S CORE
S HAP E
S IZ E
FLAVOR
BUBBLE GUM
IMPRINT CODE
CONTAINS
PACKAG IN