HELLO- potassium nitrate and sodium fluoride paste, dentifrice
Hello Products LLC

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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Hello®

Drug Facts

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)

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)

PRINCIPAL DISPLAY PANEL - 113 g Tube Box

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55882-6097-1	1 in 1 BOX	02/15/2017	03/13/2023
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	02/15/2017	03/13/2023

Labeler - Hello Products LLC (040714890)

Revised: 2/2022

Document Id: ba769f67-6f95-40c7-8f54-bb70f8a6bab2

Set id: 9a8295fe-0ab8-4a60-81b0-0823a661e646

Version: 4

Effective Time: 20220208

Hello Products LLC