ULCEREASE- phenol 0.6% anesthetic oral rinse rinse

Ulcerease by

Drug Labeling and Warnings

Ulcerease by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

0.6 % Phenol

PURPOSE

Anesthetic/Analgesic

INDICATIONS & USAGE

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

WARNINGS

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

Glycerin, Purified Water, Sodium Bicarbonate and Sodium Borate.

SAFE HANDLING WARNING

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

PRINCIPAL DISPLAY PANEL

NDC: 0316-0100-06

Ulcerease ®

Anesthetic Mouth Rinse

For prompt relief of pain due to 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

P6028.02

INGREDIENTS AND APPEARANCE

ULCEREASE 
phenol 0.6% anesthetic oral rinse rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0100-06	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/28/1977

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/28/1977

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-0100)