Ulcerease

Manufacturer
Crown Laboratories
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:18:05

Label at a glance#

ProductUlcerease
Active ingredientPHENOL
Label structure10 sections

Storage and handling

Store at room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature].

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

0.6 % Phenol

OTC - PURPOSE SECTION

Anesthetic/Analgesic

INDICATIONS & USAGE SECTION

Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.

WARNINGS SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

• 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.

STORAGE AND HANDLING SECTION

Store at room temperature 20°–25°C (68°–77°F) [See USP Controlled Room Temperature].

INACTIVE INGREDIENT SECTION

Glycerin, Purified Water, Sodium Bicarbonate and Sodium Borate.

SAFE HANDLING WARNING SECTION

TAMPER RESISTANT SEAL–IF SEAL IS BROKEN DO NOT USE.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

www.crownlaboratories.com

P6028.03

p602803p602803

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0100-062023-02-13C16284748780-1f386c64a-42bd-0266-e053-dadaa90a7c1aUlcerease Anesthetic Mouth Rinse
0316-0100-062023-01-30C16284748780-1f386c64a-42bd-0266-e053-dadaa90a7c1aUlcerease Anesthetic Mouth Rinse

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0100ULCEREASE (PHENOL 0.6% ANESTHETIC ORAL RINSE) RINSE [CROWN LABORATORIES]4Legacy NDC20231216_89689542-1741-466c-e053-2995a90a7d2b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0100-06ML - Milliliter0316-0100c5ac1572-106c-4341-9c81-3062dd9313d612019-06-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-01000316-0100-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c9326fe-9396-a166-e063-6294a90a167e89689542-1741-466c-e053-2995a90a7d2b2023-12-15WarningsExact identifier
spl id: 0c9326fe-9396-a166-e063-6294a90a167e
spl set id: 89689542-1741-466c-e053-2995a90a7d2b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.