FDA.reportPublic FDA data

Level1 Health Hand Sanitizer

Manufacturer
Level 1 Health LLC | Continental Manufacturing Chemist, Inc. | Continental Manufacturing Chemist
Effective date
2020-05-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:13:55

Label at a glance#

ProductLevel1 Health Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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

Purified water USP, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Vitamine E Acetate, Carbomer, Propylene Glycol, Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of 32 oz labelImage of 32 oz labelImage of 10 oz labelImage of 10 oz labelImage of 8.4 oz labelImage of 8.4 oz label

LEVEL 1 HEALTH

Hand Sanitizer

Premium Moisturizing Gel

Unscented

WITH ALOE + VITAMIN E

70% Alcohol Antiseptic

XX FL OZ (XXX.X mL)

MADE IN USA

Distributed by

Level 1 Health

3636 S Geyer Rd. Suite 100

St. Louis, MO 63127

www.level1health.com | (314) 238-7348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74936-001-082023-01-30C16284748780-1f386c649-aa7b-0266-e053-dadaa90a7c1aLevel 1 Health OTC hand sanitizer
74936-001-102023-01-30C16284748780-1f386c649-aa7b-0266-e053-dadaa90a7c1aLevel 1 Health OTC hand sanitizer
74936-001-322023-01-30C16284748780-1f386c649-aa7b-0266-e053-dadaa90a7c1aLevel 1 Health OTC hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74936-001-08Level1 Health Hand Sanitizer249 mL in 1 BOTTLEGEL2494
74936-001-10Level1 Health Hand Sanitizer295.7 mL in 1 BOTTLEGEL295.74
74936-001-32Level1 Health Hand Sanitizer946.4 mL in 1 BOTTLEGEL946.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74936-001LEVEL1 HEALTH HAND SANITIZER (ALCOHOL ANTISEPTIC) GEL [LEVEL 1 HEALTH LLC]4Legacy NDC, 3 package rows20200521_a4c95731-199e-1653-e053-2a95a90ae5fd.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74936-00174936-001-32, 74936-001-08, 74936-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
PEG-40 CASTOR OIL4ERD2076EFIACT

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
a61b6f10-8eac-3537-e053-2a95a90a6125a4c95731-199e-1653-e053-2a95a90ae5fd2020-05-20WarningsExact identifier
spl id: a61b6f10-8eac-3537-e053-2a95a90a6125
spl set id: a4c95731-199e-1653-e053-2a95a90ae5fd

Reported adverse events (FAERS/openFDA)#

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