Label at a glance#

ProductDenti-Care Topical Fluoride Foam Bubble Gum

Active ingredientsodium fluoride, HYDROFLUORIC ACID

Label structure6 sections

Contacts and useful links#

PhoneLabel contact1-800-361-2862

Websitewww.medicom.com

www.medicom.com

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Denti-Care

Denti-Foam

Topical Fluoride Foam Bubble Gum

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1373-1

DOSAGE & ADMINISTRATION SECTION

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)

INACTIVE INGREDIENT SECTION

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 AND PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1090053	sodium fluoride 1.76 % / hydrofluoric acid 1.04 % Oral Foam	PSN	1
1090053	hydrofluoric acid 10.4 MG/ML / sodium fluoride 17.6 MG/ML Oral Foam	SCD	1
1090053	hydrofluoric acid 1.04 % / sodium fluoride 1.76 % (fluoride ion 1.23 % ) Oral Foam	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64778-1373-1	2019-10-29	C162847	48780-1	960f7f55-d952-8e05-e053-dbdaa90a074a	Denti-Care Denti-Foam Topical Fluoride Foam Bubble Gum 1.23% Fluoride Ions

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64778-1373-1	Denti-CareTopical Fluoride Foam Bubble Gum	125 g in 1 BOTTLE, SPRAY	AEROSOL, FOAM	125		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64778-1373	DENTI-CARE TOPICAL FLUORIDE FOAM BUBBLE GUM (FLUORIDE IONS) AEROSOL, FOAM [AR MEDICOM INC]	1	Legacy NDC, 1 package rows	20110210_8f73af62-6124-4bf6-915d-4b913add7ad1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROFLUORIC ACID	ACTIVE INGREDIENT	RGL5YE86CZ	1
sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Denti-Care Topical Fluoride Foam Bubble Gum
Fluoride Ions
sodium fluoride
FLUORIDE ION
HYDROFLUORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64778-1373	64778-1373-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
sodium fluoride	8ZYQ1474W7	ACTIB
HYDROFLUORIC ACID	RGL5YE86CZ	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a24a83eb-3f91-496a-b78a-95b5a0b3db76			8f73af62-6124-4bf6-915d-4b913add7ad1	2011-02-09	Warnings	Exact identifier spl id: a24a83eb-3f91-496a-b78a-95b5a0b3db76 spl set id: 8f73af62-6124-4bf6-915d-4b913add7ad1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.