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Hello by Hello Products LLC

Medically reviewed on November 23, 2017

Dosage form: paste, dentifrice
Ingredients: Sodium fluoride 1.5mg in 1g
Labeler: Hello Products LLC
NDC Code: 55882-6096

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Box

naturally
friendly

hello®

pure mint

extra whitening
fluoride toothpaste

whitens teeth
prevents cavities
strengthens enamel
freshens breath
feels awesome

no peroxide
no artificial sweeteners
no preservatives

NET WT 4.2OZ (119g)

HELLO 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6096
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (fluoride ion) fluoride ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Hydrated Silica 
Glycerin 
Xylitol 
Water 
Calcium Carbonate 
Xanthan Gum 
Sodium Lauryl Sulfate 
Titanium Dioxide 
Stevia Rebaudiuna Leaf 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Pure Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55882-6096-11 TUBE in 1 BOX
1119 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/2016
Labeler - Hello Products LLC (040714890)
Establishment
NameAddressID/FEIOperations
Accupac, Inc.071609663MANUFACTURE(55882-6096)

 
Hello Products LLC

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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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