Storage and handling
Store at room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature].
Store at room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature].
0.6 % Phenol
Anesthetic/Analgesic
Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.
• Keep out of reach of children. • Not for ingestion.
• If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.
• Keep out of reach of children.
• Shake well prior to use.
• Use full strength as a mouth rinse, rinsing affected area for 15 seconds and spitting out the remainder of the product.
• For upper throat, gargle for 15 seconds and spit out.
• For adults and children over 12 years of age use every 2 hours or as needed; do not use more than 12 times per day.
• Children ages 4 months to under 12 years of age, apply to affected area with clean swab. Use up to 6 times daily or as directed by physician or dentist.
• For teething and hard to reach areas, apply directly to area with tip of clean swab, repeat up to 6 times daily.
Store at room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature].
Glycerin, Purified Water, Sodium Bicarbonate and Sodium Borate.
TAMPER RESISTANT SEAL–IF SEAL IS BROKEN DO NOT USE.
NDC 0316-0100-06
Ulcerease ®
Anesthetic Mouth Rinse
Quick pain relief for mouth and upper throat irritations
CONTAINS: NO SUGAR, NO ALCOHOL, NO ARTIFICIAL DYES OR COLORINGS.
PLEASANT TO USE.
Manufactured and Distributed by: Crown Laboratories Inc.,
Johnson City, TN 37604
800.334.4286
P6028.03
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0316-0100-06 | 2023-02-13 | C162847 | 48780-1 | f386c64a-42bd-0266-e053-dadaa90a7c1a | Ulcerease Anesthetic Mouth Rinse |
| 0316-0100-06 | 2023-01-30 | C162847 | 48780-1 | f386c64a-42bd-0266-e053-dadaa90a7c1a | Ulcerease Anesthetic Mouth Rinse |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0316-0100-06 | ML - Milliliter | 0316-0100 | c5ac1572-106c-4341-9c81-3062dd9313d6 | 1 | 2019-06-19 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0316-0100 | 0316-0100-06 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| PHENOL | 339NCG44TV | ACTIB |
| SODIUM BORATE | 91MBZ8H3QO | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
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 |
|---|---|---|---|---|---|---|
| 0c9326fe-9396-a166-e063-6294a90a167e | 89689542-1741-466c-e053-2995a90a7d2b | 2023-12-15 | Warnings | 0c9326fe-9396-a166-e063-6294a90a167e 89689542-1741-466c-e053-2995a90a7d2b |
Adverse event summaries are temporarily unavailable. Other product information remains available.