Kroger

Manufacturer
Kroger | Lornamead
Effective date
2016-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:40

Label at a glance#

ProductKroger Maximum Strength
Active ingredientBENZOCAINE, MENTHOL
Label structure8 sections

Indications and uses

for the temporary relief of pain due to toothaches to help protect against infection of minor oral irritation

Dosage and administration

cut open tip of tubne on score mark adults and children 2 years of age and older; apply a small amount of product to the cavity and arround 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20.0% ..................................Oral pain reliever

Menthol 0.25% .......................................Oral pain reliever

Benzalkonium Chloride 0.1% ....................Antiseptic

Uses

OTC - PURPOSE SECTION

for the temporary relief of pain due to toothaches

to help protect against infection of minor oral irritation

WARNINGS SECTION

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 more than directed
  • for more than 7 days unless told to do so by a dentist or doctor

Stop use and ask a doctor if

  • swelling rash or fever developes
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days
  • allergic reaction occurs

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.

Directions

INDICATIONS & USAGE SECTION

  • cut open tip of tubne on score mark
  • adults and children 2 years of age and older; apply a small amount of product to the cavity and arround 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

OTHER SAFETY INFORMATION

  • do not use if tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • do not use continuously
  • this formula will stay in place for an extended duration of relief
  • avoid using toothpaste or drinking softdrinks or fruit juices for at least one hour after applying

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cellulose Gum, Gelatin, Methyl Salicylate, Mineral Oil, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:
apply to affect4ed area using applicator tip
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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1.jpgMM1.jpg

MM2.jpgMM2.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-354-092020-01-31C16284748780-19d75b9d0-cc37-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-354-02KrogerMaximum Strength9.3 g in 1 TUBECREAM9.31
30142-354-09KrogerMaximum Strength1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-354KROGER MAXIMUM STRENGTH (BENZOCAINE) CREAM [KROGER]12 package rows20160729_d6340d05-d0cb-491e-ab4e-d7669a613e78.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-35430142-354-02, 30142-354-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
0252f7bc-2e61-412d-877c-0413feea660fd6340d05-d0cb-491e-ab4e-d7669a613e782016-07-29WarningsExact identifier
spl id: 0252f7bc-2e61-412d-877c-0413feea660f
spl set id: d6340d05-d0cb-491e-ab4e-d7669a613e78

Reported adverse events (FAERS/openFDA)#

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