DERMATOLOGICAL- butylated hydroxytoluene soap

DERMATOLOGICAL by

Drug Labeling and Warnings

DERMATOLOGICAL 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 %

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

INGREDIENTS AND APPEARANCE

DERMATOLOGICAL 
butylated hydroxytoluene soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79577-7000
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79577-7000-1	125 g in 1 POUCH; Type 0: Not a Combination Product	05/04/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2023

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(79577-7000)