FDA.reportPublic FDA data

Wellnicity Hand Sanitizer

Manufacturer
United Laboratories Manufacturing, LLC | Dibar Nutricional, S. de R.L. de C.V.
Effective date
2020-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:18

Label at a glance#

ProductWellnicity Hand Sanitizer
Active ingredientALCOHOL
Label structure6 sections

Indications and uses

Hand sanitizer helps reduce bacteria on the skin could cause disease.

Dosage and administration

Aplly entire packet to palm of hand. Use no water or towels. Rub until hands are completely covered.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70.0% v/v

Purpose

OTC - PURPOSE SECTION

Anti Microbial

Warnings

WARNINGS SECTION

Flammable: keep away from excessive heat or open flame.

For external use only.

Do not use 

OTC - DO NOT USE SECTION

in or near eyes. In case of eye contact, flush with water. Do not apple to open wounds or damaged skin.  

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Stop use and consult a doctor

OTC - STOP USE SECTION

if irritation occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Aplly entire packet to palm of hand. Use no water or towels. Rub until hands are completely covered.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Distilled Water, Biopol Plus / Carbomer 940, Aloe Vera Aqueous Extract, Aminomethyl Propane, Rapidgel.

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer helps reduce bacteria on the skin could cause disease.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionC:\Users\RegCorp 142\Downloads\Download SPL\Listings to submit to FDA\United Laboratories Manufacturing, LLC (73009-017) Wellnicity Hand Sanitizer

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62400-0017-1Wellnicity Hand Sanitizer2.25 mL in 1 PACKAGEGEL2.251
62400-0017-1Wellnicity Hand Sanitizer1000 in 1 BOXGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62400-0017WELLNICITY HAND SANITIZER (ALCOHOL) GEL [UNITED LABORATORIES MANUFACTURING, LLC]1Legacy NDC, 2 package rows20200731_abac7267-5392-b207-e053-2995a90ae005.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62400-001762400-0017-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
RAPIDGEL EZ133JH4A7R2KIACT
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
abac7267-5393-b207-e053-2995a90ae005abac7267-5392-b207-e053-2995a90ae0052020-07-30WarningsExact identifier
spl id: abac7267-5393-b207-e053-2995a90ae005
spl set id: abac7267-5392-b207-e053-2995a90ae005

Reported adverse events (FAERS/openFDA)#

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