Otc - Active Ingredient
Ethyl Alcohol 65% v/v. Purpose: Antiseptic
Zepol
FDA Label NDC 79198-656
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dile Enterprises Llc for the product Zepol (NDC 79198-656). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antisptic, Hand Sanitizer
Warnings
Flammable. Keep awy from fire or flame. For external use.
Otc - Do Not Use
In children less than 2 months of age
On open skin wounds
Otc - When Using
Do not use in eyes. In case of contact with eyes, rinse with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help promptly.
Dosage & Administration
Place enough product on hands to cover all surface. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing
Storage And Handling
Store between 15-30C (59-89F)
Indications & Usage
For handwashing to decrease bacteria for the skin.
Inactive Ingredient
Water, carbomer, isopropyl alcohol, triethanolamine
Package Label.Principal Display Panel
3.785 L Label (Label1)
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