FDA.reportPublic FDA data

FOOT WORKS MAXIMUM CRACKED HEEL

Manufacturer
COSMAX USA, CORPORATION
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:48:20

Label at a glance#

ProductFOOT WORKS MAXIMUM CRACKED HEEL
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE
Label structure7 sections

Indications and uses

Uses first aid to help reduce the risk of skin infection in minor cuts, scrapes and burns first aid for the temporary reflief of pain in minor cuts, scrapes and burns

Dosage and administration

Directions Adults and children 2 years of age and older clean the affected area apply a small amount of this product on the affected are 1 to 3 times daily may be covered with a sterile bandage Children under 2 years of age consult a doctor

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine 4%

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

External analgesic

USES

DOSAGE & ADMINISTRATION SECTION

Uses

  • first aid to help reduce the risk of skin infection in minor cuts, scrapes and burns
  • first aid for the temporary reflief of pain in minor cuts, scrapes and burns

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

  • do not use in the eyes or apply over large areas of the body
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • consult a doctor in the case of deep or puncture wounds, animal bites, or serious burns
  • if condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

INDICATIONS & USAGE SECTION

Directions

Adults and children 2 years of age and older

  • clean the affected area
  • apply a small amount of this product on the affected are 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age

  • consult a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water, Isopropyl Palmitate, Glyceryl Stearate, Cetyl Alcohol, Stearyl Alcohol, Glycerin, Lanolin Wax, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 80, Benzyl Alcohol, Carbomer, Methylparaben, Disodium EDTA, Allantoin, Alcohol, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PKGPKG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1356071benzalkonium chloride 0.13 % / lidocaine 4 % Topical CreamPSN1
1356071benzalkonium chloride 1.3 MG/ML / lidocaine 40 MG/ML Topical CreamSCD1
1356071benzalkonium chloride 0.13 % / lidocaine 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-195-00FOOT WORKS MAXIMUM CRACKED HEEL750 mL in 1 TUBECREAM7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-195FOOT WORKS MAXIMUM CRACKED HEEL (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [COSMAX USA, CORPORATION]1Current NDC, 1 package rows20241225_29f92230-d1d4-5e94-e063-6294a90af812.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-19568577-195-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
EDETATE DISODIUM7FLD91C86KIACT
ALLANTOIN344S277G0ZIACT
CITRIC ACID2968PHW8QPIACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERYL STEARATE230OU9XXE4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALCOHOL3K9958V90MIACT
VITIS VINIFERA (GRAPE) SEED OIL930MLC8XGGIACT
GLYCERINPDC6A3C0OXIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
DIMETHICONE92RU3N3Y1OIACT
POLYSORBATE 806OZP39ZG8HIACT
METHYLPARABENA2I8C7HI9TIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT

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
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
ndc (package): 68577-195-00
ndc (product): 68577-195
ndc11 (package): 68577019500
spl id: 29f92230-d1d5-5e94-e063-6294a90af812
spl set id: 29f92230-d1d4-5e94-e063-6294a90af812

Reported adverse events (FAERS/openFDA)#

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