ANTIFUNGAL- butylated hydroxytoluene soap

ANTIFUNGAL by

Drug Labeling and Warnings

ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by PROMAQUILA DE COCULA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT Butylhydroxytoluene (BHT) .10 %

PURPOSE

PURPOSE ANTIFUNGAL

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.

WARNINGS

WARNING

FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS

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

KEEP OUT OF REACH OF CHILDREN

STOP USE SECTION

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

USE

Use[s]

For washing to decrease bacteria and fungus on skin

INACTIVE INGREDIENTS

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

For external use only.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
butylated hydroxytoluene soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79577-9000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K)	BUTYLATED HYDROXYTOLUENE	0.001 g  in 1 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETIC ACID (UNII: 9G34HU7RV0)	0.001 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.001 g  in 1 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	0.018 g  in 1 g
GLYCERIN (UNII: PDC6A3C0OX)	0.065 g  in 1 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO)	0.8579 g  in 1 g
CALCIUM CARBONATE (UNII: H0G9379FGK)	0.046 g  in 1 g
GARLIC OIL (UNII: 4WG8U28833)	0.001 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79577-9000-9	8000 g in 1 BOX; Type 0: Not a Combination Product	06/23/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2022

Labeler - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)

Registrant - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)

Establishment
Name	Address	ID/FEI	Business Operations
PROMAQUILA DE COCULA, S.A. DE C.V.		812760470	manufacture(79577-9000)