ULCEREASE- phenol 0.6% anesthetic oral rinse rinse 
Crown Laboratories

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Ulcerease Anesthetic Mouth Rinse

0.6 % Phenol

Anesthetic/Analgesic

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

• 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.

• 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.

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

Glycerin, Purified Water, Sodium Bicarbonate and Sodium Borate.

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

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

p602803

ULCEREASE 
phenol 0.6% anesthetic oral rinse rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-0100-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product03/28/1977
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02203/28/197708/29/2025
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-0100)

Revised: 12/2023
Document Id: 0c9326fe-9396-a166-e063-6294a90a167e
Set id: 89689542-1741-466c-e053-2995a90a7d2b
Version: 4
Effective Time: 20231215
 
Crown Laboratories