Storage and handling
Storage temperatures limit: up to 30°C. Do ot use if package is damaged.
Biomin Restore Plus
- Manufacturer
- DRCOLLINS, INC.
- Effective date
- 2020-04-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:13:43
Label at a glance#
ProductBiomin Restore Plus
Active ingredientSODIUM FLUORIDE
Label structure12 sections
Label contents#
Full prescribing information#
Purpose
Anticavity & Sensitivity Relief
Indications for Use
Fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Instructions for Use
Remove foil cover from nozzle, do not use if this seal has been broken. Brush twice daily for 2 minutes, ideally first thing in the morning and last thing at night, swirl the foamy dentifrice around your mouth for 30 seconds, and spit out. Do not swallow. Avoid rinsing your mouth
with water after brushing. Replace cap after use to keep dentifrice dry.
Warnings and Precautions
Continued tooth pain or sensitivivity could indicate an inherent problem that needs professional diagnosis. If symptoms persist consult your dentist. If irritation occurs, discontinue use.
Keep Out of Reach of Children
Keep Out of Reach of Children. For Adults Use Only.
Warning
DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS
Active Ingredient
Sodium Fluoride. (Fluoride concentration is 530μg/g by weight.)
Inactive Ingredients
Glycerin, Silica, PEG 400, Cocomidapropyl Betaine, Sodium Methyl Cocoyl Taurate, Titanium Dioxide, Aroma, Carbomer, Potassium Acesulfame.
Dosage & Administration
Net Wt. 3.35oz (100g)
75ml e / 100g ℮ / 3.5oz ℮.
Storage & Handling
Storage temperatures limit: up to 30°C.
Do ot use if package is damaged.
Carton
Tube Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77055-100-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-a66d-a426-e053-dadaa90af4c2 | BioMin Restore Plus |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77055-100-01 | Biomin Restore Plus | 100 g in 1 TUBE | PASTE, DENTIFRICE | 100 | 1 | |
| 77055-100-01 | Biomin Restore Plus | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Biomin Restore Plus
- Sodium Fluoride
- SODIUM METHYL COCOYL TAURATE
- GLYCERIN
- COCAMIDOPROPYL BETAINE
- SILICON DIOXIDE
- POLYETHYLENE GLYCOL 400
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- ACESULFAME POTASSIUM
- FLUORIDE ION
- TITANIUM DIOXIDE
- PEPPERMINT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77055-100 | 77055-100-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM METHYL COCOYL TAURATE | JVL98CG53G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE | 0A5MM307FC | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PEPPERMINT | V95R5KMY2B | 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 |
|---|---|---|---|---|---|---|
| a47a410f-3a69-2024-e053-2995a90acdaf | a47a410f-3a68-2024-e053-2995a90acdaf | 2020-04-29 | Warnings | a47a410f-3a69-2024-e053-2995a90acdaf a47a410f-3a68-2024-e053-2995a90acdaf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.