PREMIUM HAND SANITIZER

Manufacturer
Vitane Pharmaceuticals, Inc.
Effective date
2020-05-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:32:18

Label at a glance#

ProductPREMIUM HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

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

Discontinue use & ask a Doctor

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Company Information

SPL UNCLASSIFIED SECTION

Distributed By:

Vitane Pharmaceuticals, Inc.

125 Wells Avenue

Congers, New York 10920, USA

www.vitanepharma.com

MADE IN GUATEMALA

Product Packaging - 280 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VITANE

Quality to Life

PREMIUM

Hand Sanitizer

HELPS KILL GERMS

TARGETS BACTERIA

ANTIMICROBIAL FORMULA

NON STERILE SOLUTION

9.5 fl. oz. (280 mL)

premium hand sanitizerpremium hand sanitizer

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60577-77460577-774-01, 60577-774-02, 60577-774-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6d650a63-d41c-4497-b564-b19b3efc9c97a49bb11b-73d7-6a1a-e053-2995a90a092e2023-09-20WarningsExact identifier
spl set id: a49bb11b-73d7-6a1a-e053-2995a90a092e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.