NuRinse

Manufacturer
NuGenTec
Effective date
2022-12-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:36

Label at a glance#

ProductNuRinse
Active ingredientHYPOCHLOROUS ACID
Label structure11 sections

Dosage and administration

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.

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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:

  1. HOCL 385ppm
  2. 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)

OTC - ACTIVE INGREDIENT SECTION

HOCL 385ppm Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

None

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

Purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​​3785 mL NDC: 77368-385-01 NuRinse HOCLNuRinse HOCL NuRinse BackNuRinse Back

3785 ml back of label3785 ml back of label

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77368-385-05NuRinse18927 mL in 1 BOTTLELIQUID189276
77368-385-08NuRinse237 mL in 1 BOTTLELIQUID2376
77368-385-12NuRinse355 mL in 1 BOTTLELIQUID3556
77368-385-16NuRinse474 mL in 1 BOTTLELIQUID4746
77368-385-55NuRinse208198 mL in 1 BOTTLELIQUID2081986
77368-385-75NuRinse10409875 mL in 1 BOTTLELIQUID104098756

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77368-385NURINSE (HAND SANITIZER HOCL) LIQUID [NUGENTEC]6Legacy NDC, 6 package rows20221223_d311852d-e33a-0f74-e053-2995a90a3863.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77368-38577368-385-05, 77368-385-55, 77368-385-75, 77368-385-08, 77368-385-12, 77368-385-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPOCHLOROUS ACID712K4CDC10ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f074239f-688b-e484-e053-2a95a90a46b5d311852d-e33a-0f74-e053-2995a90a38632022-12-22WarningsExact identifier
spl id: f074239f-688b-e484-e053-2a95a90a46b5
spl set id: d311852d-e33a-0f74-e053-2995a90a3863

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.