FLUORODINE ULTRA SENSITIVE FLUORIDE ANTICAVITY - potassium nitrate and sodium fluoride paste, dentifrice
Multibrands International Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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fluorodine ULTRA sensitive Fluoride Anticavity Toothpaste

Active Ingredient

Potassium Nitrate 5%

Sodium Fluoride 0.24%

Purpose

Anti-sensitive

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children

under 6 years of age.

Do not swallow.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older:	Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age:	Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), Supervise children as necessary until capable of using without supervision.
Children under 2 years of age:	Consult a dentist or doctor.

Inactive ingredients

Sorbitol, Water, Silicon Dioxide, Sodium Lauryl Sulfate, Flavour, Cellulose Gum, Tetrasodium Pyrophosphate, Carrageenan, Sodium Saccharin, Titanium Dioxide, Sodium Benzoate, Calcium Glycerophosphate, Hydrated Silica - Blue 1

Advanced Cleaning and Protection

MultiBrands
Manufactured for:
Multibrands International Limited.
Unit 2 Jowett Street, Bradford.
West Yorkshire BD1 2JX
United Kingdom

www.fluorodine.eu.com
Designed Developed and Formulated in Great Britain

Made in China

To report a serious adverse event,
Contact 1-315-636-4687

LOT:
USA EXP:

fluorodine ULTRA sensitive Fluoride Anticavity Toothpaste LongLasting Protection +Cleans Polishes Mircrocleaning Crystals Net Wt. 4.66 oz (132 g)

fluorodine ULTRA sensitive Fluoride Anticavity Toothpaste 132g (22975-003-00)

FLUORODINE ULTRA SENSITIVE FLUORIDE ANTICAVITY
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:22912-003
Route of Administration	DENTAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE (NITRATE ION)	POTASSIUM NITRATE	5 g in 100 g
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	0.24 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL
WATER
SILICON DIOXIDE
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
TITANIUM DIOXIDE
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM
SODIUM BENZOATE
CALCIUM GLYCEROPHOSPHATE
HYDRATED SILICA
FD&C BLUE NO. 1

#	Item Code	Package Description
Packaging
1	NDC:22912-003-00	1 in 1 PACKAGE
1		132 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	04/10/2013

Labeler - Multibrands International Ltd (236858853)

Revised: 4/2013

Document Id: 47c42d18-5a59-41da-804d-d03e2e888ade

Set id: 6081dbc9-81e8-4032-80d9-578033809fc2

Version: 1

Effective Time: 20130410

Multibrands International Ltd