FDA.reportPublic FDA data

LIFEWISE HAND SANITIZER

Manufacturer
General Wireless Operations Inc.
Effective date
2020-10-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:37

Label at a glance#

ProductLIFEWISE HAND SANITIZER
Active ingredientALCOHOL
Label structure14 sections

Dosage and administration

Apply generously. Rub all over both hands until dry.

Storage and handling

Store between 59-86°F (15-30°C). May discolor fabrics and surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To reduce germs and bacteria when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

Do not use on children less than 2 months of age or on open skin wounds.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

If irritation or rash occurs, stop use and consult a doctor. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously. Rub all over both hands until dry.

Other information

STORAGE AND HANDLING SECTION

Store between 59-86°F (15-30°C). May discolor fabrics and surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

RECENT MAJOR CHANGES SECTION

  • Update and clarify use cases, warnings, and directions of use. (8/27/2020)
  • Update label design. Added link to lifewiseusa.com. Clarified Drug Information panel. (10/29/2020)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 80019-520-01/02/03

Catalog No. 6405201/2/3

Label FrontLabel Front

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241663ethanol 80 % Topical SprayPSN2
1241663ethanol 0.8 ML/ML Topical SpraySCD2
1241663ethanol 80 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80019-520-012022-01-28C16284748780-1d6a99b39-49d3-a426-e053-dadaa90af4c2LIFEWISE HAND SANITIZER
80019-520-022022-01-28C16284748780-1d6a99b39-49d3-a426-e053-dadaa90af4c2LIFEWISE HAND SANITIZER
80019-520-032022-01-28C16284748780-1d6a99b39-49d3-a426-e053-dadaa90af4c2LIFEWISE HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80019-520-01LIFEWISE HAND SANITIZER51 mL in 1 BOTTLE, SPRAYSPRAY512
80019-520-02LIFEWISE HAND SANITIZER236 mL in 1 BOTTLE, SPRAYSPRAY2362
80019-520-03LIFEWISE HAND SANITIZER473 mL in 1 BOTTLE, SPRAYSPRAY4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80019-520LIFEWISE HAND SANITIZER (ALCOHOL) SPRAY [GENERAL WIRELESS OPERATIONS INC.]2Legacy NDC, 3 package rows20201030_aa86cdee-13f0-3ceb-e053-2995a90a4f0f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80019-52080019-520-02, 80019-520-01, 80019-520-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b2d6c985-66e2-049e-e053-2a95a90a69a0aa86cdee-13f0-3ceb-e053-2995a90a4f0f2020-10-29WarningsExact identifier
spl id: b2d6c985-66e2-049e-e053-2a95a90a69a0
spl set id: aa86cdee-13f0-3ceb-e053-2995a90a4f0f