MOUTH SORE RELIEF PROFESSIONAL STRENGTH- benzocaine liquid 
CVS Pharmacy

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.

----------

Drug Facts

Active ingredient

Benzocaine 20.0% (w/w) ...................................................................... Oral anesthetic/analgesic

Use

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

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

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.

Bottle Label
Blister label

• 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
MOUTH SORE RELIEF  PROFESSIONAL STRENGTH
benzocaine liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-830
Route of Administration ORAL DEA Schedule     
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
MENTHOL (UNII: L7T10EIP3A) 4.34 mg  in 1 g
ALCOHOL (UNII: 3K9958V90M) 280.87 mg  in 1 g
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) 0.1 mg  in 1 g
TANNIC ACID (UNII: 28F9E0DJY6) 30 mg  in 1 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) 0.5 mg  in 1 g
SUCRALOSE (UNII: 96K6UQ3ZD4) 3 mg  in 1 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 1 mg  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 50 mg  in 1 g
OLETH-10 (UNII: JD797EF70J) 5 mg  in 1 g
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 5 mg  in 1 g
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) 2 mg  in 1 g
WATER (UNII: 059QF0KO0R) 14.78 mg  in 1 g
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) 338.5 mg  in 1 g
BENZOIN (UNII: L7J6A1NE81) 10 mg  in 1 g
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
1 NDC:59779-830-31 14.7 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 10/01/2009
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
CSR Cosmetic Solutions 243501959 manufacture(59779-830) , pack(59779-830)

Revised: 4/2011
Document Id: b8178aba-50dd-4fbb-8352-bdb6ea2980ef
Set id: 1b7209f6-8368-47fa-8df2-b049613b8c1b
Version: 14
Effective Time: 20110419
 
CVS Pharmacy