FLUORODINE ULTRA ACTIVE FLUORIDE ANTICAVITY- 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 active Fluoride Anticavity Toothpaste

Active Ingredient

Sodium Fluoride 0.24%

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

Sorbitol, Water, Silicon Dioxide, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Carrageenan, Titanium Dioxide, Tetrasodium Pyrophosphate, Sodium Saccharin, Sodium Benzoate, Calcium Glycerophosphate, 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 ULTRA active Fluoride Anticavity Toothpaste LongLasting Protection +Cleans Polishes Mircrocleaning Crystals Net Wt. 4.66 oz (132 g)

fluorodine ULTRA active Fluoride Anticavity Toothpaste 132g (22912-002-00)

Ultra Active Tube Ultra Active Outer

FLUORODINE ULTRA ACTIVE FLUORIDE ANTICAVITY
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:22912-002
Route of Administration	DENTAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:22912-002-00	1 in 1 PACKAGE
1		132 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	03/27/2013	01/07/2016

Labeler - Multibrands International Ltd (236858853)

Revised: 1/2016

Document Id: 28c3b0c1-3ef7-04b4-e054-00144ff88e88

Set id: 4de8b4c7-6587-4813-ba83-e28a910ae727

Version: 3

Effective Time: 20160107

Multibrands International Ltd