ANTIFUNGAL- butylated hydroxytoluene soap 
PROMAQUILA DE COCULA, S.A. DE C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BULK ANTIFUNGAL SOAP

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

ANTIFUNGAL SOAP

ANTIFUNGAL 
butylated hydroxytoluene soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79577-9000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.001 g  in 1 g
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79577-9000-98000 g in 1 BOX; Type 0: Not a Combination Product06/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2022
Labeler - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)
Registrant - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)
Establishment
NameAddressID/FEIBusiness Operations
PROMAQUILA DE COCULA, S.A. DE C.V.812760470manufacture(79577-9000)

Revised: 6/2022
Document Id: e229e8a1-aecd-7b46-e053-2a95a90a3065
Set id: e229e8a1-aecc-7b46-e053-2a95a90a3065
Version: 1
Effective Time: 20220623
 
PROMAQUILA DE COCULA, S.A. DE C.V.