NuRinse by NuGenTec NuRinse Hand Sanitizer

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]

NURINSE- hand sanitizer who1 liquid 
NuGenTec

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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NuRinse Hand Sanitizer

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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.

Active Ingredient(s)

Alcohol 80% v/v. 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

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

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.

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 to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

​​3785 mL NDC: 77368-080-05 3785 ml label

3785 ml back of label

NURINSE 
hand sanitizer who1 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77368-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
Product Characteristics
Colorwhite (Clear Color) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77368-080-0518927 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
2NDC: 77368-080-55208198 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
3NDC: 77368-080-7510409875 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
4NDC: 77368-080-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
5NDC: 77368-080-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
6NDC: 77368-080-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
7NDC: 77368-080-022.5 mL in 1 PACKET; Type 0: Not a Combination Product05/05/2020
8NDC: 77368-080-2259.14 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/05/202004/01/2023
Labeler - NuGenTec (090331927)
Registrant - NuGenTec (090331927)
Establishment
NameAddressID/FEIBusiness Operations
NuGenTec090331927manufacture(77368-080)

Revised: 8/2023

Trademark Results [NuRinse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NURINSE
NURINSE
88895185 not registered Live/Pending
NuGeneration Technologies, LLC
2020-04-30
NURINSE
NURINSE
88861048 not registered Live/Pending
NuGeneration Technologies, LLC
2020-04-06
NURINSE
NURINSE
87418779 5339183 Live/Registered
NuGeneration Technologies, LLC
2017-04-20

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