Your browser does not support JavaScript! CVS PHARMACY MOUTH SORE GEL (BENZOCAINE) GEL, DENTIFRICE [CVS PHARMACY]
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CVS PHARMACY MOUTH SORE GEL (benzocaine) gel, dentifrice
[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 ingredients

Benzalkonium Chloride 0.02% .............................................................. Oral Antiseptic

Benzocaine 20.0% (w/w) ..................................................................... Oral Pain Reliever

Zonc Chloride 0.1% .............................................................................. Oral Astringent

Uses

temporary relieves pain caused by canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and
gums

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

  • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.
  • Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• cut open tip of tube on scoremark

  • Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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: ask a dentist or doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

allantoin, carbomer, edetate disodium, mentha piperita, polyethylene glycol, polysorbate 60, propylene glycol, propyl gallate, water, PVP, sodium saccharin, sorbic acid, stearyl alcohol

Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the the gum surrounding the teeth. 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.

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Carton label

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Tube Label

CVS PHARMACY  MOUTH SORE GEL
benzocaine gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59779-913
Route of AdministrationOralDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20.00 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.02 g  in 100 g
ZINC CHLORIDE (ZINC CATION) ZINC CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
POLYSORBATE 60 
WATER 
SACCHARIN SODIUM 
EDETATE DISODIUM 
SORBIC ACID 
STEARYL ALCOHOL 
POVIDONE K90 
CARBOMER HOMOPOLYMER TYPE B 
PROPYLENE GLYCOL 
ALLANTOIN 
PROPYL GALLATE 
Product Characteristics
Colorwhite (White clear to slight pink orange) Score    
ShapeSize
FlavorPEPPERMINT (mentha piperota) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-913-991 in 1 CARTON
1NDC:59779-913-9211.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/01/2012
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(59779-913), pack(59779-913)

Revised: 11/2012
 
CVS Pharmacy

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