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

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 TubeActive Fresh Outer

FLUORODINE ACTIVE FRESH FLUORIDE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22912-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CALCIUM BICARBONATE (UNII: 7PRA4BLM2L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22912-001-001 in 1 PACKAGE
1132 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/27/201301/07/2016
Labeler - Multibrands International Ltd (236858853)

Revised: 1/2016
 
Multibrands International Ltd