Indications and uses
Helps aid in the prevention of dental cavities.
Helps aid in the prevention of dental cavities.
Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as n...
Stannous Fluoride 0.4%
Anticavity
Helps aid in the prevention of dental cavities.
This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Do not use if the foil seal under the cap is torn, cut of missing.
Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine
1-800-558-6684
Home Care
Fluoride Gel
0.4% Stannous Fluoride
Bubblegum
Burst
11422
AIDS IN THE
PREVENTION
OF DENTAL CAVITIES
PLAK
SMACKER
Net Weight 4.3 oz (121.9 g)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72796-0412-1 | 2024-02-06 | C162847 | 48780-1 | 1030e365-4570-111a-e063-dadaa90a10e2 | Plak Smacker Stannous Gel - Bubble Gum |
| 72796-0412-1 | 2024-02-06 | C162847 | 48780-1 | 1030e365-4570-111a-e063-dadaa90a10e2 | Plak Smacker Stannous Gel - Bubble Gum |
| 72796-0412-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4570-111a-e063-dadaa90a10e2 | Plak Smacker Stannous Gel - Bubble Gum |
| 72796-0412-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4570-111a-e063-dadaa90a10e2 | Plak Smacker Stannous Gel - Bubble Gum |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72796-0412-1 | Plak Smacker | 121.9 g in 1 TUBE | GEL | 121.9 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 72796-0412 | 72796-0412-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STANNOUS FLUORIDE | 3FTR44B32Q | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| ASCORBIC ACID | PQ6CK8PD0R | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2024-02-06 | full-release | 2026-06-01 00:08:22 |
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 |
|---|---|---|---|---|---|---|
| Plak Smacker | STANNOUS FLUORIDE | Young Innovations, Inc. | e65c62d9-e8a6-3101-e053-2995a90a1494 | 2025-11-04 | Warnings | 72796-0412-1 72796-0412 72796041201 42c89f0a-b4bb-a17b-e063-6294a90a09bf e65c62d9-e8a6-3101-e053-2995a90a1494 |
Adverse event summaries are temporarily unavailable. Other product information remains available.