Premium Hand Sanitizer by VITANE PHARMACEUTICALS INC / Welburn Global, Sociedad Anonima

Premium Hand Sanitizer by

Drug Labeling and Warnings

Premium Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by VITANE PHARMACEUTICALS INC, Welburn Global, Sociedad Anonima. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREMIUM HAND SANITIZER- alcohol gel 
VITANE PHARMACEUTICALS INC

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) (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. Glycerin (0.5% v/v).
3. Sterile distilled water or boiled cold water.

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

• 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

Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butyl Carbamate, Methylisothiazolinone.

Package Label - Principal Display Panel

3785 mL NDC: 60577-774-03

PREMIUM HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60577-774
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60577-774-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2020	09/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/20/2020	09/20/2023

Labeler - VITANE PHARMACEUTICALS INC (029029638)

Establishment
Name	Address	ID/FEI	Business Operations
Welburn Global, Sociedad Anonima		817579163	manufacture(60577-774)

Revised: 7/2020

Document Id: 3001eb58-86a7-4ee9-a635-88d9b7074345

34390-5

Set id: aae30efd-f7eb-a47a-e053-2a95a90affe8

Version: 2

Effective Time: 20200720