Zanitz by Zolutek GMC, S.A. de C.V.

Zanitz by

Drug Labeling and Warnings

Zanitz by is a Otc medication manufactured, distributed, or labeled by Zolutek GMC, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZANITZ- alcohol gel 
Zolutek GMC, S.A. de C.V.

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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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.

To 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 skin irritation or rash appears and lasts. 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 in your palm to thoroughly cover your hands. Rubs hands together firmly until dry. No rinsing or towels needed. Not recomended for infants; for children under 6, use only with adult supervision.

Other information

• Do not store above 110 °F (43°C).
• May discolor certain fabrics

Inactive ingredients

Glycerin, hydrogen peroxide, water.

Package Label - Principal Display Panel

3785 mL NDC: 79472-002-01

ZANITZ 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79472-002
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
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79472-002-01	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/13/2020	01/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/13/2020	01/24/2022

Labeler - Zolutek GMC, S.A. de C.V. (951578010)

Registrant - Zolutek GMC, S.A. de C.V. (951578010)

Establishment
Name	Address	ID/FEI	Business Operations
Zolutek GMC, S.A. de C.V.		951578010	manufacture(79472-002)

Revised: 1/2022

Document Id: d67101e1-aac7-6491-e053-2a95a90a3c71

34390-5

Set id: a9e33a4b-4bc5-ce7d-e053-2a95a90a0fdf

Version: 3

Effective Time: 20220125