Sanitizer by Nutraze, S.C de R.L. de C.V.

Sanitizer by

Drug Labeling and Warnings

Sanitizer by is a Otc medication manufactured, distributed, or labeled by Nutraze, S.C de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANITIZER- alcohol, citric acid liquid 
Nutraze, S.C de R.L. de C.V.

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Active ingredient

Alcohol 80% Purpose: Antiseptic

Inactive ingredients

Glycerin, hydrogen peroxide, purifed water.

Use(s)

Hand Sanitizer Antiseptic solution to help reduce bateria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable. Keep away from heat or flame.

- In children less than 2 months of age

- In open skin wounds

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Antiseptic

If irritation or rash occurs. These may be signs of a serious condition.

If irritation or rash occurs. These may be signs of a serious condition.

If swallowed, get medical help, or contact a Poison Control Center right away.

Other information

- Store between 15-30°C (59-86°F)

- Avoid freezing and excessive heat above 40°C (104°F)

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.

Topical

Principal Display Panel

500 mL NDC: 77578-003-01

Package Label- Principal Display Panel

1000 L NDC: 77578-003-02

SANITIZER 
alcohol, citric acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77578-003
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
WATER (UNII: 059QF0KO0R)	18.425 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77578-003-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020	11/01/2024
2	NDC: 77578-003-02	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/16/2020	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/16/2020	11/01/2024

Labeler - Nutraze, S.C de R.L. de C.V. (951577481)

Registrant - Nutraze, S.C de R.L. de C.V. (951577481)

Establishment
Name	Address	ID/FEI	Business Operations
Nutraze, S.C de R.L. de C.V.		951577481	manufacture(77578-003)

Revised: 11/2024

Document Id: 25dcc1eb-f90e-b960-e063-6394a90acb3c

34390-5

Set id: aa1b7ea7-c755-ebce-e053-2995a90ad016

Version: 4

Effective Time: 20241101