FDA.reportPublic FDA data

WELKIN Hand Sanitizer

Manufacturer
Ningbo SKL International Co.,Ltd.
Effective date
2020-08-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:23:58

Label at a glance#

ProductWELKIN Hand Sanitizer
Active ingredientALCOHOL
Label structure9 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

Do not store above 105°F. May discolor some fabrics. Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% (v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

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

Do not use

  • on children less than 2 months old.
  • on open skin wounds.

When using this product

  • keep out of eyes, In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin.
  • do not inhale or ingest.

Stop use and ask a doctor if

  • irritation or redness develops.
  • Condition persists for more than 72 hours.

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

  • Do not store above 105°F.
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aminomethyl propanol, carbomer, homopolymer, glycerin, propylene glycol, purified water USPglycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74542-014-012022-01-28C16284748780-1d6a99b39-df1b-a426-e053-dadaa90af4c228778de2-a4ce-4cda-8e9a-5edfd6cd9204
74542-014-022022-01-28C16284748780-1d6a99b39-df1b-a426-e053-dadaa90af4c228778de2-a4ce-4cda-8e9a-5edfd6cd9204
74542-014-032022-01-28C16284748780-1d6a99b39-df1b-a426-e053-dadaa90af4c228778de2-a4ce-4cda-8e9a-5edfd6cd9204
74542-014-042022-01-28C16284748780-1d6a99b39-df1b-a426-e053-dadaa90af4c228778de2-a4ce-4cda-8e9a-5edfd6cd9204
74542-014-052022-01-28C16284748780-1d6a99b39-df1b-a426-e053-dadaa90af4c228778de2-a4ce-4cda-8e9a-5edfd6cd9204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74542-014-01WELKIN Hand Sanitizer2 mL in 1 POUCHGEL22
74542-014-02WELKIN Hand Sanitizer1 mL in 1 POUCHGEL12
74542-014-03WELKIN Hand Sanitizer3 mL in 1 POUCHGEL32
74542-014-04WELKIN Hand Sanitizer4 mL in 1 POUCHGEL42
74542-014-05WELKIN Hand Sanitizer5 mL in 1 POUCHGEL52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74542-014WELKIN HAND SANITIZER (ALCOHOL) GEL [NINGBO SKL INTERNATIONAL CO.,LTD.]2Legacy NDC, 5 package rows20200807_28778de2-a4ce-4cda-8e9a-5edfd6cd9204.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
74542-01474542-014-01, 74542-014-02, 74542-014-03, 74542-014-04, 74542-014-05

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
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER TYPE AF68VH75CJCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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
1ab622ad-38f3-4f17-abb2-919cabecbadb28778de2-a4ce-4cda-8e9a-5edfd6cd92042020-08-05WarningsExact identifier
spl id: 1ab622ad-38f3-4f17-abb2-919cabecbadb
spl set id: 28778de2-a4ce-4cda-8e9a-5edfd6cd9204

Reported adverse events (FAERS/openFDA)#

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