FDA.reportPublic FDA data

DERMATOLOGICAL

Manufacturer
PROMAQUILA DE COCULA, S.A. DE C.V.
Effective date
2023-05-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:55:08

Label at a glance#

ProductDERMATOLOGICAL
Active ingredientALCOHOL, BUTYLATED HYDROXYTOLUENE
Label structure11 sections

Dosage and administration

DIRECTIONS Wet your hands with clean water take the bar of soap and foam it. Thoroughly rub your hands between fingers all inside and outside surfaces,nails. Rinse your hands with clean water.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT Butylhydroxytoluene (BHT) .10 %

ALCOHOL

PURPOSE

OTC - PURPOSE SECTION

PURPOSE ANTIFUNGAL

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

Wet your hands with clean water take the bar of soap and foam it. Thoroughly rub your hands between fingers all inside and outside surfaces,nails. Rinse your hands with clean water.

WARNINGS

WARNINGS AND PRECAUTIONS SECTION

WARNING

FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

WARNINGS AND PRECAUTIONS

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

USE

INDICATIONS & USAGE SECTION

Use[s]

For washing to decrease bacteria and fungus on skin

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Soap base paste (Sodium Tallowate, Beef, Sodium Cocoate)
Sodium laureth-3 sulfate

Pomegranate & Sunflower Fragrance

Calendula Officinalis Flower
Edetic Acid

WARNING SECTION

WARNINGS SECTION

For external use only.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMATOLOGICAL SOAP 125 FINALDERMATOLOGICAL SOAP 125 FINAL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79577-7000-12024-07-30C16284748780-11030e365-2518-111a-e063-dadaa90a10e2DERMATOLOGICAL SOAP
79577-7000-12024-01-30C16284748780-11030e365-2518-111a-e063-dadaa90a10e2DERMATOLOGICAL SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79577-7000-1DERMATOLOGICAL125 g in 1 POUCHSOAP1254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79577-7000DERMATOLOGICAL (BUTYLATED HYDROXYTOLUENE) SOAP [PROMAQUILA DE COCULA, S.A. DE C.V.]41 package rows20230531_fb78538e-e728-42ec-e053-6294a90af52a.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79577-700079577-7000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
EDETIC ACID9G34HU7RV0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KACTIB
SODIUM TALLOWATE, BEEF07RIK6QMEWIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SODIUM COCOATER1TQH25F4IIACT

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
fcd992d8-d97c-85f2-e053-6394a90a7c8bfb78538e-e728-42ec-e053-6294a90af52a2023-05-29WarningsExact identifier
spl id: fcd992d8-d97c-85f2-e053-6394a90a7c8b
spl set id: fb78538e-e728-42ec-e053-6294a90af52a

Reported adverse events (FAERS/openFDA)#

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