NuRinse Hand Sanitiizer Gel

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- ethyl alcohol lemon gel 
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 Sanitiizer Gel

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.
5. Hydroxymethyl Cellulose (7g per 100ml)
6. Lemon Fragrance (0.01% 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 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, lemon fragrance, Hydroxymethyl Cellulose

Package Label - Principal Display Panel

3785mL NDC: 77368-181-01

NURINSE 
ethyl alcohol lemon gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77368-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)	7 g  in 100 mL
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.01 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77368-181-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
2	NDC: 77368-181-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
3	NDC: 77368-181-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
4	NDC: 77368-181-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
5	NDC: 77368-181-55	208198 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
6	NDC: 77368-181-05	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
7	NDC: 77368-181-75	1040987.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020	04/01/2023

Labeler - NuGenTec (090331927)

Registrant - NuGenTec (090331927)

Establishment
Name	Address	ID/FEI	Business Operations
NuGenTec		090331927	manufacture(77368-181)

Revised: 8/2023

Document Id: 02203a4d-c933-7f3f-e063-6394a90ade71

34390-5

Set id: ae842d6b-aa64-a5c6-e053-2995a90af385

Version: 6

Effective Time: 20230804