Active Ingredient Section
ACTIVE INGREDIENT Butylhydroxytoluene (BHT) .10 %
Dermatological
FDA Label NDC 79577-7000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Promaquila De Cocula, S.a. De C.v. for the product Dermatological (NDC 79577-7000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, purpose, dosage and administration, warnings, warnings and precautions, keep out of reach of children, stop use section, use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Sodium lauryl ether sulfate
calendula essence
Ethylenediaminetetraacetic Acid
(EDTA)
Warning Section
For external use only.
* Please review the disclaimer below.
