NURINSE- hand sanitizer hocl aloe and vitamin e gel gel 
NuGenTec

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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NuRinse Hand Sanitizer HOCL Aloe and Vitamin E Gel

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 and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Purified water USP

Hydroxmethyl Cellulose

Package Label - Principal Display Panel

NuRinse Back​​3785 mL NDC: 77368-388-01 NuRinse HOCL gel front

NURINSE 
hand sanitizer hocl aloe and vitamin e gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77368-388
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.000385 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) 7 g  in 100 mL
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9) 0.0005 g  in 100 mL
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2) 0.0005 g  in 100 mL
Product Characteristics
Colorwhite (Clear Color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77368-388-0518927 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
2NDC:77368-388-55208198 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
3NDC:77368-388-7510409875 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
4NDC:77368-388-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
5NDC:77368-388-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
6NDC:77368-388-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/05/2020
Labeler - NuGenTec (090331927)
Registrant - NuGenTec (090331927)
Establishment
NameAddressID/FEIBusiness Operations
NuGenTec090331927manufacture(77368-388)

Revised: 12/2022
Document Id: f0741faf-3e43-9966-e053-2995a90a0178
Set id: d9bfd81f-7fd1-24df-e053-2995a90af0da
Version: 8
Effective Time: 20221222
 
NuGenTec