Hello
- Manufacturer
- Hello Products LLC | Lornamead Inc.
- Effective date
- 2019-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:32:55
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium fluoride 0.24%
(0.15% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Anticavity
INDICATIONS & USAGE SECTION
Use
Helps protect against cavities.
WARNINGS SECTION
Warnings
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- Adults and 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 physician.
INACTIVE INGREDIENT SECTION
Inactive Ingredients
Sorbitol, Hydrated Silica, Purified Water, Glycerin, Xylitol, Flavor, Xanthan Gum, Titanium Dioxide,Cocamidopropyl Betaine, Sodium Cocoyl Glutamate and Stevia Rebaudiana Leaf Extract.
OTC - QUESTIONS SECTION
Questions? 855-HI-HELLO (1-855-444-3556)
SPL UNCLASSIFIED SECTION
Distributed by Hello Products LLC Montclair, NJ 07042
©2017 Hello Products LLC,
www.helloproducts.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
naturally friendly™
hello® bubblegum
fluoride toothpaste
prevents cavities
strengthens enamel
tastes awesome
polishes + brightens
no artificial sweeteners. no dyes. no preservatives. no SLS/sulfates.
kids ages 2+
NET WT 4.2 OZ (119g)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55882-6025-1 | 2023-03-03 | C162847 | 48780-1 | ab0e2407-28a2-f274-e053-dbdaa90a6471 | Hello Fluoride Toothpaste - Bubble Gum - SLS Free |
| 55882-6025-1 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-28a2-f274-e053-dbdaa90a6471 | Hello Fluoride Toothpaste - Bubble Gum - SLS Free |
| 55882-6025-1 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-28a2-f274-e053-dbdaa90a6471 | Hello Fluoride Toothpaste - Bubble Gum - SLS Free |
| 55882-6025-1 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28a2-f274-e053-dbdaa90a6471 | Hello Fluoride Toothpaste - Bubble Gum - SLS Free |
Products#
Every source-derived product name is available through these pages.
- Hello Bubble Gum - SLS Free
- Sodium fluoride
- HYDRATED SILICA
- GLYCERIN
- XYLITOL
- XANTHAN GUM
- SODIUM COCOYL GLUTAMATE
- STEVIA REBAUDIUNA LEAF
- FLUORIDE ION
- SORBITOL
- WATER
- TITANIUM DIOXIDE
- COCAMIDOPROPYL BETAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55882-6025 | 55882-6025-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| SODIUM COCOYL GLUTAMATE | BMT4RCZ3HG | IACT |
| STEVIA REBAUDIUNA LEAF | 6TC6NN0876 | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIB |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | 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 |
|---|---|---|---|---|---|---|
| 27ccef2f-3a8d-4fad-a62c-e756631dfa38 | 809c2c28-a8a8-24e9-e053-2a91aa0a3b36 | 2019-01-29 | Warnings | 809c2c28-a8a8-24e9-e053-2a91aa0a3b36 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
