ULCEREASE- phenol 0.6% anesthetic oral rinse rinse

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)
Available from:
Crown Laboratories
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anesthetic/Analgesic Temporary relief of occasional minor irritation, pain, sore mouth, sore throat, canker sores and teething.
Authorization status:
OTC monograph not final
Authorization number:
0316-0100-06

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

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

®

ULCEREASE

phenol 0.6% anesthetic oral rinse rinse

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 316 -0 10 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENO L (UNII: 339 NCG44TV) (PHENOL - UNII:339 NCG44TV)

PHENOL

6 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM BO RATE (UNII: 9 1MBZ8 H3QO)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 316 -0 10 0 -0 6

178 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/28 /19 77

Marketing Information

Crown Laboratories

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 3/28 /19 77

Labeler -

Crown Laboratories (079035945)

Registrant -

Crown Laboratories (079035945)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Cro wn Labo rato ries

0 79 0 359 45

ma nufa c ture (0 316 -0 10 0 )

Revised: 5/2019

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