OTC Medication Information: CVS Pharmacy Mouth Sore Gel

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.

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
(click image for full-size original)

mm2.jpg

Tube Label
(click image for full-size original)
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 (BENZOCAINE) BENZOCAINE 20 g in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.02 g in 100 g
ZINC CHLORIDE (ZINC CATION) ZINC CATION 0.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Color white (White clear to slight pink orange) Score
Shape Size
Flavor PEPPERMINT (mentha piperota) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-913-99 1 TUBE in 1 CARTON contains a TUBE (59779-913-92)
1 NDC:59779-913-92 11.9 g in 1 TUBE This package is contained within the CARTON (59779-913-99)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 10/01/2012 02/19/2023
Labeler — CVS Pharmacy (062312574)
Registrant — Lornamead (080046418)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 manufacture (59779-913), pack (59779-913)

Revised: 07/2021 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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