ANTIFUNGAL

Manufacturer: PROMAQUILA DE COCULA, S.A. DE C.V.
Effective date: 2022-06-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:50:10

Label at a glance#

ProductANTIFUNGAL

Active ingredientBUTYLATED HYDROXYTOLUENE, ALCOHOL

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 %

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 Sebate, Sodium Cocoate)
Calcium carbonate
Ethylenediaminetetraacetic Acid
(EDTA)
Titanium Dioxide
Alcohol Based Garlic Extract, allium sativum l. bulb extract
Glycerin
Sodium lauryl ether sulfate

WARNING SECTION

WARNINGS SECTION

For external use only.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTIFUNGAL SOAP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79577-9000-9	ANTIFUNGAL	8000 g in 1 BOX	SOAP	8000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79577-9000	ANTIFUNGAL (BUTYLATED HYDROXYTOLUENE) SOAP [PROMAQUILA DE COCULA, S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20220715_e229e8a1-aecc-7b46-e053-2a95a90a3065.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

ANTIFUNGAL
BUTYLATED HYDROXYTOLUENE
EDETIC ACID
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
GLYCERIN
SODIUM BICARBONATE
CALCIUM CARBONATE
GARLIC OIL
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79577-9000	79577-9000-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EDETIC ACID	9G34HU7RV0	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
GLYCERIN	PDC6A3C0OX	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	ACTIB
SODIUM BICARBONATE	8MDF5V39QO	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
GARLIC OIL	4WG8U28833	IACT
ALCOHOL	3K9958V90M	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e229e8a1-aecd-7b46-e053-2a95a90a3065			e229e8a1-aecc-7b46-e053-2a95a90a3065	2022-06-23	Warnings	Exact identifier spl id: e229e8a1-aecd-7b46-e053-2a95a90a3065 spl set id: e229e8a1-aecc-7b46-e053-2a95a90a3065

Reported adverse events (FAERS/openFDA)#

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