HELLO- sodium fluoride paste, dentifrice 
Navajo Manufacturing Company 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.

----------

Hello ®

Drug Facts

Active Ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

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

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

Twist off cap to remove foil seal.

Do not use if safety seal is missing or broken.

Directions

  • Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.
  • Do not swallow.
  • Children under 6 years of age: Use a pea-sized amount and supervise until good brushing habits are established to minimize swallowing.
  • Children under 2 years of age: Consult a dentist or a physician.

Inactive Ingredients

Sorbitol, Hydrated Silica, Glycerin, Xylitol, Purified Water, Calcium Carbonate, Flavor, Xanthan Gum, Sodium Lauryl Sulfate, Titanium Dioxide and Stevia Rebaudiana Leaf Extract.

Questions?

855-HI-HELLO (1-855-444-3556)

Distributed by Hello Products LLC Montclair, NJ 07042

© 2016 Hello Products LLC Greet freely: www.helloproducts.com

PRINCIPAL DISPLAY PANEL

Hello Toothpaste

HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-189(NDC:55882-6096)
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINT (Pure Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67751-189-011 in 1 BLISTER PACK12/16/201605/31/2019
124.1 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/16/201605/31/2019
Labeler - Navajo Manufacturing Company Inc. (091917799)
Registrant - Navajo Manufacturing Company Incorporated (136941411)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc.136941411relabel(67751-189)

Revised: 10/2019
Document Id: 956dae14-18f4-2ece-e053-2995a90a895a
Set id: 75a0b022-d28f-cec0-e053-2991aa0a4cf2
Version: 2
Effective Time: 20191021
 
Navajo Manufacturing Company Inc.