CVS PHARMACY MOUTH SORE GEL- benzocaine, benzalkonium chloride and zinc chloride gel, dentifrice 
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.

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Drug Facts

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59779-913
Route of Administration Oral DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20.00 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.02 g  in 100 g
ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CHLORIDE 0.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBIC ACID (UNII: X045WJ989B)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALLANTOIN (UNII: 344S277G0Z)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
Product Characteristics
Color white (White clear to slight pink orange) Score     
Shape Size
Flavor PEPPERMINT (mentha piperota) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-913-99 1 in 1 CARTON
1 NDC:59779-913-92 11.9 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 10/01/2012
Labeler - CVS Pharmacy (062312574)
Registrant - Lornamead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(59779-913) , pack(59779-913)

Revised: 11/2012
Document Id: de38b65d-5091-47e8-b160-76b398f9998f
Set id: 77f84651-7706-4042-acdd-dc68ba97771d
Version: 1
Effective Time: 20121115
 
CVS Pharmacy