ULCEREASE- phenol 0.6% anesthetic oral rinse rinse 
Crown Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 not finalpart35603/28/1977
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-0100)

Revised: 2/2023
 
Crown Laboratories