HELLO- potassium nitrate and sodium fluoride paste, dentifrice

Hello by

Drug Labeling and Warnings

Hello by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Potassium nitrate 5%	Antisensitivity
Sodium fluoride 0.24%; (0.15% w/v fluoride ion)	Anticavity

Uses

• Builds increasing protection against painful sensitivity of teeth to cold, heat, acids, sweets or contact.
• Aids in the prevention of dental cavities.

Warnings

When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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

Directions

Adults and children 12 years of age and older:

• Apply at least a 1 inch strip of the product onto a soft bristle toothbrush
• Brush teeth thoroughly, for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
• Children under 12 years of age: Consult a dentist or a physician.

Inactive Ingredients

Sorbitol, Hydrated Silica, Purified Water, Xylitol, Aloe Vera Gel, Glycerin, Flavor, Coconut Oil, Xanthan Gum, Titanium Dioxide, Cocamidopropyl Betaine, Sodium Cocoyl Glutamate and Stevia Rebaudiana Leaf Extract1.

1 Certified Organic

Questions?

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

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Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 113 g Tube Box

naturally
friendly™
hello®

soothing mint
with coconut oil

never tested
on animals

sensitivity relief
fluoride toothpaste

relieves sensitivity pain
whitens teeth gently
protects enamel
prevents cavities
tastes awesome

no dyes
no sls
no artificial sweeteners
no preservatives

NET WT 4 OZ (113g)

INGREDIENTS AND APPEARANCE

HELLO 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6097
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium nitrate (UNII: RU45X2JN0Z) (nitrate ion - UNII:T93E9Y2844)	Potassium nitrate	50 mg  in 1 g
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)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)
Coconut Oil (UNII: Q9L0O73W7L)
Xanthan Gum (UNII: TTV12P4NEE)
Titanium Dioxide (UNII: 15FIX9V2JP)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Soothing Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6097-1	1 in 1 BOX	02/15/2017
1		113 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 not final	part356	02/15/2017

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	MANUFACTURE(55882-6097)