Otc - Active Ingredient
Ethyl Alcohol (80%)
Hand Sanitizer
FDA Label NDC 19392-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bullet Line, Llc for the product Hand Sanitizer (NDC 19392-150). 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, indications & usage, warnings, inactive ingredient, dosage & administration, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antiseptic
Indications & Usage
Hand sanitizing to reduce bacteria on the skin. Recommended for repeated use.
Warnings
For external use only. Keep out of eyes. Keep out of reach of children. Flammable - keep away from open flame. Do not use in or near the eyes. Stop use and ask a doctor if irritation or rash appears and if swallowed contact a doctor or poison control center right away.
Inactive Ingredient
Glycerin, Hydrogen Peroxide, Purified Water USP
Dosage & Administration
Wet hands thoroughly with product and allow to dry without wiping.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Package Label.Principal Display Panel
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