DENTI-CARE TOPICAL FLUORIDE FOAM BUBBLE GUM- fluoride ions aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O), HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

AR Medicom Inc

INN (International Name):

sodium fluoride

Composition:

sodium fluoride .0176 g in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Denti-Care Denti-Foam Topical Fluoride Foam Bubble Gum 1.23 % Fluoride Ions 4.4 oz / 125 g NDC 64778-1373-1

Authorization status:

unapproved drug other

Summary of Product characteristics

DENTI-CARE TOPICAL FLUORIDE FOAM BUBBLE GUM- FLUORIDE IONS AEROSOL,
FOAM
AR MEDICOM INC
_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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DENTI-CARE DENTI-FOAM TOPICAL FLUORIDE FOAM BUBBLE GUM 1.23% FLUORIDE
IONS
Denti-Care
Denti-Foam
Topical Fluoride Foam Bubble Gum
1.23 % Fluoride Ions
4.4 oz / 125 g
NDC 64778-1373-1
A topical anti-caries preparation
Directions (for professional use only):
1. Use after thorough prophylaxis
2. To dispense, shake bottle vigorously then invert applicator 180
degrees downward to the bottom of
the tray(s)
Note: fill tray(s) at one quarter full to allow foam to expand
3. Insert tray(s) in mouth and have patient bite down lightly for 1
minute or up to 4 minutes
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the
application
130 applications
Medicinal ingredients:
Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04%
hydrofluoric acid)
Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone
C30, glycerin USP,
propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid,
purified water, bubble gum
flavor
Warnings: KEEP OUT OF REACH OF CHILDREN
Avoid spraying toward open flame. Store at room temperature. Do not
expose to excessive heat over 40
degrees C or 104 degrees F. Contents under pressure. Do not puncture
and incinerate.
Do not use if seal is broken.
Rx Only
Manufactured in Canada for
AR Medicom Inc
Montreal, Canada, H8T 3J8
Questions 1-800-361-2862 or www.medicom.com
UPC 686864008668
Item code 10037-BG
Rev 00
DENTI-CARE TOPICAL FLUORIDE FOAM BUBBLE GUM
fluoride ions aerosol, foam
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 4778 -1373
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 - UN