SAFETYMAXX MINT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [FSI, INC.]

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  • SAFETYMAXX MINT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [FSI, INC.]

SAFETYMAXX MINT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [FSI, INC.]
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NDC 60371-344-06, 60371-344-15, 60371-344-46, 60371-344-85
Set ID b291454e-ca22-4986-819f-100b331b18c8
Category HUMAN OTC DRUG LABEL
Packager FSi, Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • 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

  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    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)
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