FDA Label for Nurinse
View Indications, Usage & Precautions
Nurinse Product Label
The following document was submitted to the FDA by the labeler of this product Nugentec. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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) consistent with World Health Organization (WHO) recommendations:
- HOCL 385ppm
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
HOCl solutions are already included in the WHO list of coronavirus-effective biocides, and in the US EPA ‘N’ list of disinfecting agents able to control emerging pathogens like SARS-CoV-2. 37,126 More than ten branded aqueous HOCl formulations have been cleared by the US FDA for topical use in wound management over the last decade. A Class III medical product approval for HOCl has been granted in the EU, and the Japanese Ministry of Health has approved use of HOCl for topical medical applications. The US FDA has approved HOCl for high level disinfection and sterilization of medical instruments, including those for use at critical (i.e., sterile) sites
Active Ingredient(S)
HOCL 385ppm Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
None
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
- 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.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
- Avoid Direct Sunlight, store in an opaque bottle.
- Keep sealed when not in use.
Inactive Ingredients
Purified water USP
Hydroxmethyl Cellulose
Aloe
Vitamin E
Package Label - Principal Display Panel
3785 mL NDC: 77368-389-01
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