FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Weckerle Cosmetics LLC
Effective date
2020-07-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:21:30

Label at a glance#

ProductHAND SANITIZER
Active ingredientAlcohol
Label structure9 sections

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 the product.

Storage and handling

Store below 110°F (43°C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Anti-microbial

Use

INDICATIONS & USAGE SECTION

  • Hand Sanitizer to help reduce bacteria on skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 the product.

Other Information

STORAGE AND HANDLING SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water , Glycerin, Propanediol, Panthenol, Aminomethyl Propanol, Carbomer, Fragrance, Carthamus Tinctorius (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Sodium Hyaluronate, Green 5, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

precos

HAND
SANITIZER
GEL

KILLS
99.9%
OF GERMS
& BACTERIA

WITH ALOE VERA
& PRO VITAMIN B5
TO MOISTURIZE

OCEAN

3.4 FL OZ / 100mL

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62516-001-012022-01-28C16284748780-1d6a99b39-5d31-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62516-001-01HAND SANITIZER100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62516-001HAND SANITIZER (ALCOHOL) GEL [WECKERLE COSMETICS LLC]1Legacy NDC, 1 package rows20200716_37729c44-c53a-428b-bf9e-f4cc3f888a62.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62516-00162516-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Alcohol3K9958V90MACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propanediol5965N8W85TIACT
PanthenolWV9CM0O67ZIACT
AminomethylpropanolLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
Safflower Oil65UEH262ISIACT
CucumberYY7C30VXJTIACT
Aloe Vera LeafZY81Z83H0XIACT
PhenoxyethanolHIE492ZZ3TIACT
Hyaluronate SodiumYSE9PPT4THIACT
D&C Green No. 58J6RDU8L9XIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT

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
41383987-d195-4acf-80be-7458f6ef150037729c44-c53a-428b-bf9e-f4cc3f888a622020-07-13WarningsExact identifier
spl id: 41383987-d195-4acf-80be-7458f6ef1500
spl set id: 37729c44-c53a-428b-bf9e-f4cc3f888a62

Reported adverse events (FAERS/openFDA)#

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