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Drug Labeling and Warnings

Drug Details [pdf]

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.

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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 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-189(NDC: 55882-6096)
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor	MINT (Pure Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-189-01	1 in 1 BLISTER PACK	12/16/2016	05/31/2019
1		24.1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/16/2016	05/31/2019

Labeler - Navajo Manufacturing Company Inc. (091917799)

Registrant - Navajo Manufacturing Company Incorporated (136941411)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-189)

Revised: 10/2019

Document Id: 956dae14-18f4-2ece-e053-2995a90a895a

34390-5

Set id: 75a0b022-d28f-cec0-e053-2991aa0a4cf2

Version: 2

Effective Time: 20191021