Indications and uses
Builds increasing protection against painful sensitivity of teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities.
Hello
- Manufacturer
- Hello Products LLC | Lornamead
- Effective date
- 2022-02-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:08:53
Label at a glance#
ProductHello
Active ingredientPotassium nitrate, Sodium fluoride
Label structure9 sections
Dosage and administration
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.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| 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
OTC - WHEN USING SECTION
When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
Questions?
855-HI-HELLO (1-855-444-3556)
SPL UNCLASSIFIED SECTION
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)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55882-6097-1 | 2022-02-10 | C162847 | 48780-1 | 9d75b9d1-0fae-f424-e053-dadaa90a57ce | Hello ® |
| 55882-6097-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0fae-f424-e053-dadaa90a57ce | Hello ® |
Products#
Every source-derived product name is available through these pages.
- Hello
- Potassium nitrate and Sodium fluoride
- Potassium nitrate
- nitrate ion
- Sodium fluoride
- fluoride ion
- Sorbitol
- Hydrated silica
- Water
- Xylitol
- Aloe Vera Leaf
- Glycerin
- Coconut Oil
- Xanthan Gum
- Titanium Dioxide
- Cocamidopropyl Betaine
- Sodium Cocoyl Glutamate
- Stevia Rebaudiuna Leaf
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55882-6097 | 55882-6097-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Potassium nitrate | RU45X2JN0Z | ACTIB |
| Sodium fluoride | 8ZYQ1474W7 | ACTIM |
| Sorbitol | 506T60A25R | IACT |
| Hydrated silica | Y6O7T4G8P9 | IACT |
| Water | 059QF0KO0R | IACT |
| Xylitol | VCQ006KQ1E | IACT |
| Aloe Vera Leaf | ZY81Z83H0X | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Coconut Oil | Q9L0O73W7L | IACT |
| Xanthan Gum | TTV12P4NEE | IACT |
| Titanium Dioxide | 15FIX9V2JP | IACT |
| Cocamidopropyl Betaine | 5OCF3O11KX | IACT |
| Sodium Cocoyl Glutamate | BMT4RCZ3HG | IACT |
| Stevia Rebaudiuna Leaf | 6TC6NN0876 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ba769f67-6f95-40c7-8f54-bb70f8a6bab2 | 9a8295fe-0ab8-4a60-81b0-0823a661e646 | 2022-02-08 | Warnings | 9a8295fe-0ab8-4a60-81b0-0823a661e646 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.