DENTICARE PRO-GEL NEUTRAL SODIUM FLUORIDE- sodium fluoride gel

DentiCare Pro-Gel by

Drug Labeling and Warnings

DentiCare Pro-Gel by is a Prescription medication manufactured, distributed, or labeled by AMD Medicom Inc, AMD Medicom Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

General Information

AMD Medicom Inc.

DentiCare Pro-Gel

1.1% Neutral Sodium Fluoride Gel for Topical Fluoride Applications (0.5% fluoride ion)

Mint

2 fl oz / 59 mL

NDC: 64778-0226-1

NPN 80008841

Rx Only for US

Item code 10022-2M

Indications and Directions

Indications: Topical anti-carie preparation in pH 7 thixotropic gel base

.
Home Care Directions for use:

1. Use only on the advice of a dentist
2. Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes
3. Expectorate and rinse well

Do not eat or drink for 30 minutes after application.

Non-Medicinal Ingredients

water, saccharin sodium, hydroxyethyl cellulose, phosphoric acid, glycerin, spearmint oil, sodium hydroxide

Warnings

KEEP OUT OF REACH OF CHILDREN

Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

Do not use if seal is broken

Contact Information

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

DENTICARE PRO-GEL  NEUTRAL SODIUM FLUORIDE
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0226
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.011 g  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0226-3	24 in 1 CASE	12/01/2017
1	NDC: 64778-0226-1	51 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2017

Labeler - AMD Medicom Inc (256880576)

Registrant - AMD Medicom Inc. (256880576)