The following Structured Product Label (SPL) was submitted to the FDA by Hygienic Labs, Llc. for the product Kleenswell Gel Hand Sanitizer (NDC 79692-003). 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 ingredients, 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.
KLEENSWELL GEL HAND SANITIZER - 70% alcohol gel
Hygienic Labs, LLC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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This is hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation).
Medicinal ingredient: Ethyl alcohol 70% v/v............... Purpose: Antiseptic
Antiseptic, Hand Sanitizer
Hand Sanitizer to help reduce viruses and 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.
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.
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.
Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone
Dosage and Administration Section was added
3800 mL NDC: 79692-003-01
19000 mL NDC: 79692-003-05
189000 mL NDC: 79692-003-50
* Please review the disclaimer below.
