MOUTH SORE RELIEF PROFESSIONAL STRENGTH- benzocaine liquid

Mouth Sore Relief by

Drug Labeling and Warnings

Mouth Sore Relief by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzocaine 20% (w/w)

Purpose

Oral Anesthetic/Analgesic

Uses

for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

WARNINGS

For oral use only

Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics
When using this product do not use for more than 7 days unless directed by a dentist or doctor.
If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away.

Directions

• to assure formation of long-lasting film coating, dry affected area and apply medication undiluted with applicator
• allow a few seconds for coating to form
• use up to 4 times daily, or as directed by a dentist or doctor
• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor
  

Other Information

do not use if package has been opened
store at 20-25˚C (68-77°F)
close cap tightly after use to avoid evaporation
avoid contact with eyes
avoid contact with clothing and household/furniture surfaces to prevent possible staining
this is a personal care item, and should be used by one individual only

Inactive ingredients

Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamide/acrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor)
Seed Oil, SD Alcohol 38B, Sucralose,Tannic Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOUTH SORE RELIEF   PROFESSIONAL STRENGTH
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-830
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
TANNIC ACID (UNII: 28F9E0DJY6)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OLETH-10 (UNII: JD797EF70J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
BENZOIN, (+/-) (UNII: L7J6A1NE81)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Mint Flavor #25797)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-830-38	1 in 1 BLISTER PACK	04/19/2011
1		14.7 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/01/2009

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
CSR Cosmetic Solutions		243501959	manufacture(59779-830) , pack(59779-830)