DERMATOLOGICAL- 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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DERMATOLOGICAL SOAP

ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT Butylhydroxytoluene (BHT) .10 %

ALCOHOL

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 Tallowate, Beef, Sodium Cocoate)
Sodium laureth-3 sulfate

Pomegranate & Sunflower Fragrance

Calendula Officinalis Flower
Edetic Acid

WARNING SECTION

For external use only.

PRINCIPAL DISPLAY PANEL

DERMATOLOGICAL SOAP 125 FINAL

DERMATOLOGICAL 
butylated hydroxytoluene soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79577-7000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.001 g  in 1 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
EDETIC ACID (UNII: 9G34HU7RV0) 0.001 g  in 1 g
SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW) 0.8622 g  in 1 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.1 g  in 1 g
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) 0.194 g  in 1 g
SODIUM COCOATE (UNII: R1TQH25F4I) 0.0957 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79577-7000-1125 g in 1 POUCH; Type 0: Not a Combination Product05/04/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2023
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(79577-7000)

Revised: 5/2023
Document Id: fcd992d8-d97c-85f2-e053-6394a90a7c8b
Set id: fb78538e-e728-42ec-e053-6294a90af52a
Version: 4
Effective Time: 20230529
 
PROMAQUILA DE COCULA, S.A. DE C.V.