FLUORODINE ACTIVE FRESH FLUORIDE ANTICAVITY - sodium monofluorophosphate 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 ACTIVE fresh Fluoride Anticavity Toothpaste

Active Ingredient

Sodium Monofluorophosphate 0.8%

Purpose

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

Calcium Carbonate, Sorbitol, Water, Glycerin, Silicon Dioxide, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Carrageenan, Sodium Phosphate, Hydroxyethyl Cellulose, Sodium Saccharin, Calcium Bicarbonate, Sodium Benzoate, Tetrasodium Pyrophosphate, Hydrated Silica - Blue 1

Advanced Cleaning and Protection

Fluorodine Active Fresh contains an advanced formula to bring a cleaner, fresher, look to your teeth. With long lasting care, new calcium enriched Fluorodine fights cavities and reduces decay. Enjoy the cool minty flavour and smile with extra confidence. Have a cleaner, fresher, look to your teeth.

CLEANS TEETH
MICROCLEANING CRYSTALS
FIGHT CAVITIES AND DECAY
COOL FRESH BREATH
BRIGHTER SMILE

fluorodine
Multibrands International and Fluorodine are registered trade marks. Designed, Develops and Formulated in Great Britain.

12M For best quality, use within 12 months after opening.

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 ACTIVE fresh Fluoride Anticavity Toothpaste LongLasting Protection +Cleans Polishes Mircrocleaning Crystals Net Wt. 4.66 oz (132 g)

fluorodine ACTIVE fresh Fluoride Anticavity Toothpaste 132g (22912-001-00)

Active Fresh Tube Active Fresh Outer

FLUORODINE ACTIVE FRESH FLUORIDE ANTICAVITY
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:22912-001
Route of Administration	DENTAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	FLUORIDE ION	0.8 g in 100 g

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

#	Item Code	Package Description
Packaging
1	NDC:22912-001-00	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	03/27/2013

Labeler - Multibrands International Ltd (236858853)

Revised: 3/2013

Document Id: 350eb3cb-72f0-43cf-b06a-eb0e6c89c7b8

Set id: e01be189-f156-43b7-b1ef-3304d8c7e95b

Version: 1

Effective Time: 20130327

Multibrands International Ltd