Indications and uses
Aids in the prevention of dental decay.
LINHART
- Manufacturer
- Nutrix International,LLC | Nutrix International, LLC
- Effective date
- 2020-01-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:56
Label at a glance#
ProductLINHART
Active ingredientSODIUM FLUORIDE
Label structure10 sections
Dosage and administration
Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Sodium Fluoride 0.25%
Purpose
Anticavity
Indications and Usage
Aids in the prevention of dental decay.
Warnings
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach section
Keep out of reach of children under 6 years of age.
Directions
- Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
- Instruct children 6 years of age in good brushing and rinsing habits (to minimize swallowing), and and only use a pea size amount.
- Supervise children as necessary until capable of using without supervision.
- Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Sorbitol, Water (Purified), Hydrated Silica, Xylitol, Glycerin, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum,Disodium Phosphate, Aloe Barbadensis Leaf Juice, Allantoin, Sodium Saccharin, Theobromine,Bisobolol.
Questions
(212) 599-2397
Primary Packaging Label
Packaging Label - Carton
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73333-096-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9fb1-a426-e053-dadaa90af4c2 | 9c4997ea-590b-47e0-e053-2a95a90ab4a9 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73333-096-03 | LINHART | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 73333-096-03 | LINHART | 96 g in 1 TUBE | PASTE, DENTIFRICE | 96 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- LINHART
- Sodium Fluoride Toothpaste
- SORBITOL
- HYDRATED SILICA
- SODIUM LAURYL SULFATE
- SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
- WATER
- GLYCERIN
- SILICON DIOXIDE
- SODIUM FLUORIDE
- FLUORIDE ION
- TITANIUM DIOXIDE
- CARBOXYMETHYLCELLULOSE
- ALOE VERA LEAF
- SACCHARIN SODIUM
- SACCHARIN
- .ALPHA.-BISABOLOL, (+/-)-
- THEOBROMINE
- XYLITOL
- ALLANTOIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73333-096 | 73333-096-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 9c49666c-3443-47e6-e053-2a95a90ad7a5 | 9c4997ea-590b-47e0-e053-2a95a90ab4a9 | 2020-01-16 | Warnings | 9c49666c-3443-47e6-e053-2a95a90ad7a5 9c4997ea-590b-47e0-e053-2a95a90ab4a9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.