FDA.reportPublic FDA data

Lewcizer 3

Manufacturer
A.P. Nonweiler Co., Inc.
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:32:33

Label at a glance#

ProductLewcizer 3
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

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 heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogen peroxide, aloe vera gel, sterile water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 74829-359-08

500 mL500 mL

946.35 mL NDC: 74829-359-04

946.35 mL NDC: 74829-359-04946.35 mL NDC: 74829-359-04

3785.41 mL NDC: 74829-359-01

GallonGallon

18927.06 mL NDC: 74829-359-05

PailPail

208197.65 mL NDC: 74829-359-50

DrumDrum

1040988.24 mL NDC: 74829-359-25

ToteTote

3785.41 mL NDC: 74829-359-01IS2

3785.41 mL NDC: 74829-359-01IS23785.41 mL NDC: 74829-359-01IS2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74829-359-012022-01-28C16284748780-1d6a99b39-fde6-a426-e053-dadaa90af4c2a3e915c9-1b5c-c268-e053-2a95a90a857b
74829-359-042022-01-28C16284748780-1d6a99b39-fde6-a426-e053-dadaa90af4c2a3e915c9-1b5c-c268-e053-2a95a90a857b
74829-359-052022-01-28C16284748780-1d6a99b39-fde6-a426-e053-dadaa90af4c2a3e915c9-1b5c-c268-e053-2a95a90a857b
74829-359-082022-01-28C16284748780-1d6a99b39-fde6-a426-e053-dadaa90af4c2a3e915c9-1b5c-c268-e053-2a95a90a857b
74829-359-252022-01-28C16284748780-1d6a99b39-fde6-a426-e053-dadaa90af4c2a3e915c9-1b5c-c268-e053-2a95a90a857b
74829-359-502022-01-28C16284748780-1d6a99b39-fde6-a426-e053-dadaa90af4c2a3e915c9-1b5c-c268-e053-2a95a90a857b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74829-359-01Lewcizer 33785.41 mL in 1 BOTTLELIQUID3785.414
74829-359-04Lewcizer 3946.35 mL in 1 BOTTLELIQUID946.354
74829-359-05Lewcizer 318927.06 mL in 1 PAILLIQUID18927.064
74829-359-08Lewcizer 3500 mL in 1 BOTTLE, PLASTICLIQUID5004
74829-359-25Lewcizer 31040988.24 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID1040988.244
74829-359-50Lewcizer 3208197.65 mL in 1 DRUMLIQUID208197.654

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74829-359LEWCIZER 3 (ALCOHOL) LIQUID [A.P. NONWEILER CO., INC.]4Legacy NDC, 6 package rows20201029_a3e915c9-1b5c-c268-e053-2a95a90a857b.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74829-35974829-359-04, 74829-359-01, 74829-359-05, 74829-359-50, 74829-359-25, 74829-359-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302IACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML · Source PDF

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
b2bc3267-924b-2497-e053-2a95a90a26c8a3e915c9-1b5c-c268-e053-2a95a90a857b2020-10-28WarningsExact identifier
spl id: b2bc3267-924b-2497-e053-2a95a90a26c8
spl set id: a3e915c9-1b5c-c268-e053-2a95a90a857b

Reported adverse events (FAERS/openFDA)#

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