Active Ingredient(S)
Ethyl Alcohol 62% v/v. Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 61531-389
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Paklab for the product Hand Sanitizer (NDC 61531-389). 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(s), purpose, use, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
Warnings
For external use only. Flammable. Keep away from heat or flame
Otc - When Using
When using this product avoid contact with face, eyes, and broken skin. If eyes contact occurs, flush thoroughly with water and seek medical advice.
Stop use and ask a doctor if irritation or rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Wet hand thoroughly with product and rub into skin until dry.
- Children under 6 years of age should be supervised by an adult when using this product.
Inactive Ingredients
aqua (water, eau), propylene glycol, glycerin, carbomer, aminomethyl propanol, isopropyl myristate, t-butyl alcohol
Package Label - Principal Display Panel
221 mL NDC: 61531-389-01
* Please review the disclaimer below.
