Indications and uses
Aids in the prevention of cavities
Plak Smacker
- Manufacturer
- LMZ
- Effective date
- 2021-03-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:39:05
Label at a glance#
ProductPlak Smacker Mint Blast
Active ingredientSODIUM FLUORIDE
Label structure7 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 a physician. Children 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established. Children under 2 years: Ask a dentist or a physician.
Label contents#
Full prescribing information#
Active Ingredients
Sodium Fluoride 0.243% (equivalent to 0.13% w/v fluoride ion)
Purpose
Anti-cavity
Uses
Aids in the prevention of cavities
Warnings
If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.
OTC - KEEP OUT OF REACH OF CHILDREN 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 a physician.
Children 2 to 6 years: To minimize swallowing use a pea sized amount. Supervise children's brushing until good habits are established.
Children under 2 years: Ask a dentist or a physician.
Inactive Ingredients
Sorbitol, Silica, Water, PEG-8, Sodium lauryl sulfate, Flavor, Titanium dioxide, Cellulose gum, Trisodium phosphate, Sodium saccharin, Xanthan gum, Benzyl alcohol, Xylitol, CI 42090
Principal Display Panel
28 g NDC: 71775-080-01
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 891775 | sodium fluoride 0.243 % Toothpaste | PSN | 1 |
| 891775 | sodium fluoride 0.00243 MG/MG Toothpaste | SCD | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste | SY | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste | SY | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste | SY | 1 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71775-080-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1519-0266-e053-dadaa90a7c1a | Mint Blast Toothpaste |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71775-080-01 | Plak SmackerMint Blast | 28 g in 1 TUBE | PASTE | 28 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Plak Smacker Mint Blast
- Sodium Fluoride
- FLUORIDE ION
- POLYETHYLENE GLYCOL 400
- BENZYL ALCOHOL
- XYLITOL
- SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
- CARBOXYMETHYLCELLULOSE
- SACCHARIN SODIUM
- SORBITOL
- SILICON DIOXIDE
- WATER
- SODIUM LAURYL SULFATE
- TITANIUM DIOXIDE
- XANTHAN GUM
- FD&C BLUE NO. 1
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71775-080 | 71775-080-01 |
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 |
|---|---|---|---|---|---|---|
| bdd574e2-7d95-64b9-e053-2995a90a0386 | bdd574e2-7d94-64b9-e053-2995a90a0386 | 2021-03-18 | Warnings | bdd574e2-7d95-64b9-e053-2995a90a0386 bdd574e2-7d94-64b9-e053-2995a90a0386 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.