Storage and handling
Other information store at room temperature 20-25°C (68-77°F) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously.
Other information store at room temperature 20-25°C (68-77°F) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously.
Active ingredient Purpose
Benzocaine 20%........................................................... Oral pain reliever
Uses
For the temporary relief of pain due to:
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
Allery Alert: do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Other information
Inactive ingredients
glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol
DISTRIBUTED BY:
WINCO FOODS, LLC
BOISE, ID 83704
MADE IN CHINA
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0070552241152 | GTIN-13: 0070552241152 EAN-13: 0070552241152 GTIN-12: 070552241152 UPC-A: 070552241152 GTIN storage (14 digits): 00070552241152 | 24115-ZDP-BX WIN Max Strength Oral Analgesic Gel 0.42oz-R1_FDA (2).jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67091-198-11 | WinCo Foods Maximum Strength Oral Analgesic | 1 in 1 CARTON | GEL | 1 | 10 | |
| 67091-198-11 | WinCo Foods Maximum Strength Oral Analgesic | 11.9 g in 1 TUBE | GEL | 11.9 | 10 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZOCAINE | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| BENZOCAINE | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67091-198 | 67091-198-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 9 | 2024-12-20 | full-release | 2026-06-01 00:47:50 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | SOLUTION / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | SOLUTION / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | OINTMENT / TOPICAL | 45 %w/w | ||
| POLYETHYLENE GLYCOL 4000 | POLYETHYLENE GLYCOL 4000 | 4R4HFI6D95 | OINTMENT / TOPICAL | 45 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | AEROSOL, FOAM / TOPICAL | 4.95 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | EMULSION / TOPICAL | 7 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | GEL / DENTAL | 0.3 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | OINTMENT / TOPICAL | 10 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CREAM / TOPICAL | 36.8 %w/w |
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 |
|---|---|---|---|---|---|---|
| WinCo Foods Maximum Strength Oral Analgesic | BENZOCAINE | WinCo Foods, LLC | c22a7726-8c3f-41bf-b852-8456b2be6f93 | 2025-10-28 | Warnings | 67091-198-11 67091-198 67091019811 423c9e30-ec85-57c9-e063-6294a90a24f9 c22a7726-8c3f-41bf-b852-8456b2be6f93 |
Adverse event summaries are temporarily unavailable. Other product information remains available.