PREMIUM HAND SANITIZER- alcohol gel

PREMIUM HAND SANITIZER by

Drug Labeling and Warnings

PREMIUM HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Vitane Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Uses

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 fire or flame.

When using this product

avoid contact with eyes, ears and mouth. In case of eye contact, flush eyes with water.

Discontinue use & 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.

Do not use

for children less than 2 months of age & on open wounds.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.

Storage

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

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

Company Information

Distributed By:

Vitane Pharmaceuticals, Inc.

125 Wells Avenue

Congers, New York 10920, USA

www.vitanepharma.com

MADE IN GUATEMALA

Product Packaging - 280 ml

VITANE

Quality to Life

PREMIUM

Hand Sanitizer

HELPS KILL GERMS

TARGETS BACTERIA

ANTIMICROBIAL FORMULA

NON STERILE SOLUTION

9.5 fl. oz. (280 mL)

INGREDIENTS AND APPEARANCE

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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60577-774-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2020
2	NDC: 60577-774-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2020
3	NDC: 60577-774-03	280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - Vitane Pharmaceuticals, Inc. (029029638)