Otc - Active Ingredient
Alcohol
The Aegis Prime Hand Sanitizer
FDA Label NDC 76627-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wowbiotech for the product The Aegis Prime Hand Sanitizer (NDC 76627-0004). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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
Inactive Ingredient
water, carbomer, triethanolamine, glycerin, butylene glycol, propylene glycol, fragrance(lemon-001s)
Otc - Purpose
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
- in children less than 2 months of age
- on open skin wounds
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash 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.
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
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