HANDY SOLUTIONS MINT FLUORIDE TOOTH- sodium fluoride paste 
Navajo Manufacturing Co., 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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Handy Solutions Mint Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium Fluoride 0.25%

Purpose

Anticavity

Use

helps protect against cavities

Warnings

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

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center Immediately

Directions

Adults and children 2 years and older. Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician. Children under 6 years: To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a dentist or physician

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Polyethylene Glycol-32, Flavor, Saccharin Sodium, Cellulose Gum, Titanium Dioxide, Sodium Benzoate.

Questions?

Call 1-800-525-5097

Product Label

Box

HANDY SOLUTIONS MINT FLUORIDE TOOTH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-035
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-035-011 in 1 BOX
178 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/21/2015
Labeler - Navajo Manufacturing Co., Inc. (091917799)

Revised: 6/2015
Document Id: 98bc728d-2f0e-449f-9459-21b0aa00d95f
Set id: c367ea05-c2af-4496-a003-3cbb7da6e7c2
Version: 1
Effective Time: 20150621
 
Navajo Manufacturing Co., Inc.