Otc - Active Ingredient
Benzalkonium Chloride (.20%). Purpose: Antiseptic
Hand Sanitizer
FDA Label NDC 78522-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northmed Sia for the product Hand Sanitizer (NDC 78522-104). 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, storage and handling, otc - do not use, otc - stop use, otc - 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
Otc - Purpose
Antiseptic. Hand Sanitizer.
Indications & Usage
Sanitizer to help reduce bacteria on hands. Recommended for repeated use.
Warnings
For external use only.
Storage And Handling
Should not be sotred below 41F/5C or above 104F/40C.
Otc - Do Not Use
Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
Otc - Stop Use
Stop use and ask a doctor if irritation and rendess develop and persists for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison control center immediately.
Dosage & Administration
Apply to hands and rub into the surface of the hands until completely absorbed.
Inactive Ingredient
Water, Glycerin, Panthenol, Aloe Vera, Tetrasodium Glutamate Diacetate.
Package Label.Principal Display Panel
2 fl. oz. 59ml. NDC: 78522-100-00
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