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Ulcerease Anesthetic Mouth Rinse


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