FDA.reportPublic FDA data

CVS Pharmacy

Manufacturer
CVS Pharmacy | Lornamead Inc.
Effective date
2021-07-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:40:22

Label at a glance#

ProductCVS Pharmacy Mouth Sore
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE, ZINC CHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Benzalkonium Chloride 0.02%

Benzocaine 20%

Zinc Chloride 0.1%

OTC - PURPOSE SECTION

Purpose

Oral Antiseptic

Oral Pain Reliever

Oral Astringent

INDICATIONS & USAGE SECTION

Uses

temporarily relieves pain caused by

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation or injury of the mouth and gums
  • to help against infection of minor oral irritation

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a dentist or doctor.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • cut open tip of tube on scoremark
  • do not use if tip is cut prior to opening
  • adults and children 2 years of age and older: apply to affected area 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.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Allantoin, Carbomer, Edetate Disodium, Mentha Piperita (Peppermint) Oil, Polyethylene Glycol, Polysorbate 60, Propylene Glycol, Propyl Gallate, Purified Water, PVP, Sodium Saccharin, Sorbic Acid, Stearyl Alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton labelCarton label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-35869842-358-98

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)K6MOM3T5YLIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 60CAL22UVI4MIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBIC ACIDX045WJ989BIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EDETATE DISODIUM7FLD91C86KIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ALLANTOIN344S277G0ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYL GALLATE8D4SNN7V92IACT
MENTHA PIPERITA79M2M2UDA9IACT
BENZOCAINEU3RSY48JW5ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ZINC CHLORIDE86Q357L16BACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c73ee985-836a-9639-e053-2995a90af97b4f4dc81e-5d75-4837-92c7-9fe1465afcaf2021-07-16WarningsExact identifier
spl id: c73ee985-836a-9639-e053-2995a90af97b
spl set id: 4f4dc81e-5d75-4837-92c7-9fe1465afcaf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.