NURINSE- ethyl alcohol lemon foam 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 Guidelines established by the CDC.

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) (70%, 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.
  5. Peg-10 Dimethicone (0.9% v/v)

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 70% 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

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, Peg-10 Dimethicone, Lemon Fragrance

Package Label - Principal Display Panel

NuRinse 70% 1 gal gel Foam LemonNuRinse 70% 1 gal gel back3785 mL NDC: 77368-172-01

NURINSE 
ethyl alcohol lemon foam liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77368-174
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.01 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) 0.9 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
Product Characteristics
Colorwhite (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77368-174-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
2NDC:77368-174-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
3NDC:77368-174-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
4NDC:77368-174-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
5NDC:77368-174-0518927 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
6NDC:77368-174-55208198 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
7NDC:77368-174-751040988 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - NuGenTec (090331927)
Registrant - NuGenTec (090331927)
Establishment
NameAddressID/FEIBusiness Operations
NuGenTec090331927manufacture(77368-174)

Revised: 12/2022
Document Id: f0741174-25cc-07a0-e053-2995a90a5fa3
Set id: b74e0663-f102-c8f6-e053-2a95a90a0bd0
Version: 6
Effective Time: 20221222
 
NuGenTec