Storage and handling
Other information Store in a cool, dry place. Keep tube capped when not in use.
Family Wellness
- Manufacturer
- Family Dollar Services Inc. | Lornamead Inc.
- Effective date
- 2021-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:40:26
Label at a glance#
ProductFamily Wellness Maximum Strength
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Potassium nitrate 5%
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Antihypersensitivity
Anticavity
INDICATIONS & USAGE SECTION
Uses
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
- aids in the prevention oif dental cavities
WARNINGS SECTION
Warnings
OTC - WHEN USING SECTION
When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.
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 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 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 one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
- Children under 12 years of age: consult a dentist or physician.
INACTIVE INGREDIENT SECTION
Inactive ingredients sorbitol, hydrated silica, water, glycerin, pentasodium tripolyphosphate, PEG-8, flavor, titanium dioxide, cocamidopropyl betaine, sodium methyl cocoyl taurate, xanthan gum, sodium hydroxide, sodium saccharin
STORAGE AND HANDLING SECTION
Other information
Store in a cool, dry place. Keep tube capped when not in use.
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD.
MATTHEWS, NC 28105
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FAMILY WELLNESS
MAXIMUM STRENGTH
Sensitive Toothpaste
Fluoride Toothpaste for Sensitive Teeth & Cavity Protection
Extra Whitening
NET WT 4 OZ (113 g)
Products#
Every source-derived product name is available through these pages.
- Family Wellness Maximum Strength
- Potassium nitrate, Sodium fluoride
- WATER
- SACCHARIN SODIUM
- SODIUM TRIPOLYPHOSPHATE
- POLYETHYLENE GLYCOL 400
- SORBITOL
- TITANIUM DIOXIDE
- SODIUM HYDROXIDE
- GLYCERIN
- XANTHAN GUM
- HYDRATED SILICA
- COCAMIDOPROPYL BETAINE
- SODIUM METHYL COCOYL TAURATE
- SODIUM FLUORIDE
- FLUORIDE ION
- POTASSIUM NITRATE
- NITRATE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-383 | 55319-383-19 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM TRIPOLYPHOSPHATE | 5HK03SA80J | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| SODIUM METHYL COCOYL TAURATE | JVL98CG53G | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| POTASSIUM NITRATE | RU45X2JN0Z | ACTIB |
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 |
|---|---|---|---|---|---|---|
| c73de23c-7ec1-373b-e053-2995a90aa5d7 | 8245dfea-4b7e-3979-e053-2991aa0ae25a | 2021-07-16 | Warnings | c73de23c-7ec1-373b-e053-2995a90aa5d7 8245dfea-4b7e-3979-e053-2991aa0ae25a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.