Label: ULCEREASE- phenol 0.6% anesthetic oral rinse rinse
- NDC Code(s): 0316-0100-06
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 15, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- SAFE HANDLING WARNING
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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
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INGREDIENTS AND APPEARANCE
ULCEREASE
phenol 0.6% anesthetic oral rinse rinseProduct 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) SODIUM BORATE (UNII: 91MBZ8H3QO) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BICARBONATE (UNII: 8MDF5V39QO) 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 Drug M022 03/28/1977 08/29/2025 Labeler - Crown Laboratories (079035945) Registrant - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-0100)