The following Structured Product Label (SPL) was submitted to the FDA by Artesanales P.r. Llc for the product Neat Hand Sanitizer (NDC 78824-615). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Alcohol 80% v/v. Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
For external use only. Flammable. Keep away from heat or flame
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes 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.
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.
glycerin, hydrogen peroxide, purified water USP
Neat 8oz (Neat Handsan 8oz)
Neat 16 Oz (Neat Handsan 16oz)
* Please review the disclaimer below.
