Your browser does not support JavaScript! MOUTH SORE RELIEF PROFESSIONAL STRENGTH (BENZOCAINE) LIQUID [CVS PHARMACY]
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MOUTH SORE RELIEF PROFESSIONAL STRENGTH (benzocaine) liquid
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-830
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL4.34 mg  in 1 g
ALCOHOL280.87 mg  in 1 g
ETHYLCELLULOSES0.1 mg  in 1 g
TANNIC ACID30 mg  in 1 g
CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 g
SUCRALOSE3 mg  in 1 g
BENZYL ALCOHOL1 mg  in 1 g
PROPYLENE GLYCOL50 mg  in 1 g
OLETH-105 mg  in 1 g
DIMETHYL ISOSORBIDE5 mg  in 1 g
RICINUS COMMUNIS SEED2 mg  in 1 g
WATER14.78 mg  in 1 g
POLYETHYLENE GLYCOL 300338.5 mg  in 1 g
BENZOIN10 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Mint Flavor #25797) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-830-381 in 1 BLISTER PACK
1NDC:59779-830-3114.7 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/01/2009
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions243501959manufacture(59779-830), pack(59779-830)

Revised: 4/2011
 
CVS Pharmacy

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