Antibacterial Hand Sanitizing
FDA Label NDC 78080-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Makmac Inc for the product Antibacterial Hand Sanitizing (NDC 78080-001). 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 drug facts, active ingredient, purpose, use, warnings, when using this product, stop use and ask doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 70% v/v
Purpose
Antiseptic
Use
- Antibacterial hand sanitizing gel to help killing bacteria and germs as antiseptic on the skin. For use when soap and water are not available.
Warnings
Flammable. Keep away from fire or flame.
For external use only
When Using This Product
keep out of eyes and mouth. In case of contact with eyes, immediately rinse eyes thoroughly with water
Stop Use And Ask Doctor
If irritation, rash or allergy occurs. These may be signs of a serious condition
Keep Out Of Reach Of Children.
If swallowed get medical help or contact a poison control center right away
Directions
- Apply. Put enough product on hands to cover all surfaces. Rub hands together, until hands feel dry. This should take around 20 seconds. recommended for repeated use.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
• Store between 59-86°F (15-30°C) avoid freezing and excessive heat above 104°F (40°C)
Inactive Ingredients
• Deionized Water. Carbomer. Panthenol. D-Limonene. DMDM Hydantoin. Disodium EDTA Triethanolamine.
Package Labeling
Label (Label)
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