SAFETYMAXX MINT FLAVOR - sodium fluoride gel, dentifrice 
FSi, Inc.

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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SafetyMAXX Mint Flavor

Active Ingredient

Sodium Fluoride - 0.22% (0.1%w/v fluoride ion)

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

Purified water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, 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 Toothgel

SAFETYMAXX MINT FLAVOR 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60371-344
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60371-344-0617 g in 1 TUBE
2NDC:60371-344-8524 g in 1 TUBE
3NDC:60371-344-1543 g in 1 TUBE
4NDC:60371-344-46130 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
Document Id: 11fc8a8a-b455-4c65-978a-914282ee1993
Set id: b291454e-ca22-4986-819f-100b331b18c8
Version: 1
Effective Time: 20111115
 
FSi, Inc.