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SafetyMAXX Mint Flavor by FSi, Inc.

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.76g in 100g
Labeler: FSi, Inc.
NDC Code: 60371-339

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.

SafetyMAXX Mint Flavor

Active Ingredient

Sodium Monofluorophosphate - 0.76% (Total fluoride content - 1000ppm Approx)

Purpose

Anticavity

Use:

Helps protect against cavities

Warnings

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

Keep out of reach of children under 6years of age.

Directions

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: ask a dentist or physician

Inactive Ingredients

Calcium carbonate, Purified Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, methylparaben, Titanium Dioxide, Polyethylene Glycol 400 Propyl Paraben

Product of China, Exclusively produced for FSi, Inc. 1-800-647-5923 www.myfsi.net Expires 2 years from the DAte of Mfg

FSi, Inc Nashville TN 37210

Product Tube Label

SAFETYMAXX MINT FLAVOR 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60371-339
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
WATER 
SORBITOL 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM SILICATE 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM DIHYDRATE 
METHYLPARABEN 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 400 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:60371-339-0617 g in 1 TUBE
2NDC:60371-339-8524 g in 1 TUBE
3NDC:60371-339-1543 g in 1 TUBE
4NDC:60371-339-2778 g in 1 TUBE
5NDC:60371-339-46130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/15/2011
Labeler - FSi, Inc. (609296694)

Revised: 11/2011
 
FSi, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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