NURINSE- hand sanitizer hocl liquid

NuRinse by

Drug Labeling and Warnings

NuRinse by is a Otc medication manufactured, distributed, or labeled by NuGenTec. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

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.

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

Package Label - Principal Display Panel

​​3785 mL NDC: 77368-385-01

INGREDIENTS AND APPEARANCE

NURINSE 
hand sanitizer hocl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77368-385
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10)	HYPOCHLOROUS ACID	0.000385 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Clear Color)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77368-385-05	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020
2	NDC: 77368-385-55	208198 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020
3	NDC: 77368-385-75	10409875 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020
4	NDC: 77368-385-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020
5	NDC: 77368-385-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020
6	NDC: 77368-385-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/05/2020

Labeler - NuGenTec (090331927)

Registrant - NuGenTec (090331927)

Establishment
Name	Address	ID/FEI	Business Operations
NuGenTec		090331927	manufacture(77368-385)