FDA Label for Ulcerease
View Indications, Usage & Precautions
Ulcerease Product Label
The following document was submitted to the FDA by the labeler of this product Crown Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
0.6 % Phenol
Otc - 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.
Otc - 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.
Package Label.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
* Please review the disclaimer below.
