Active Ingredient
benzalkonium chloride 0.20%
Hand Sanitizer
FDA Label NDC 78522-101
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 for the product Hand Sanitizer (NDC 78522-101). 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, purpose, use(s), warnings, otc - do not use, otc - when using, stop use, 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
Purpose
Antiseptic
Use(S)
Use(s). Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only.
Otc - Do Not Use
Do not use: in children less than 2 months of age; on open skin wounds.
Otc - When Using
When using this product: keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop Use
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
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions
Directions. Apply a small amount of gel to the hands and massage. Wait for it to dry. The exposure time is 15-30 seconds. Supervise children under 6 years of age when using this product to avoid swallowing.
Storage.
Store between 41-80F (5-27C). Avoid freezing and excessive heat above 104F (40C).
Inactive Ingredients
Inactive Ingredients.Water. glycerin, panthenol, aloe vera, hydroxyethyl cellulose, tetrasodium glutamate diacetate, fragrance, chamomile extract, birch leaf extract, elderberry extract.
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