FDA.reportPublic FDA data

STERITOUCH HAND SANITIZER

Manufacturer
WELABLE HEALTHCARE
Effective date
2020-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:50

Label at a glance#

ProductSTERITOUCH HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use for use • when soap and water are not available

Dosage and administration

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use for use • when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire/flame
For external use only

Do not use • in children less than 2 months of age • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

  • irritation and redness develop
  • 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

• wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C(104°F)

Inactive ingredients 

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, water 

Questions? 

OTC - QUESTIONS SECTION

+ 1-801-392-0937
You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Distributed by: S.K.P. LLC, 2105 s 1100 W, West Haven, UT 84401


COUNTRY OF ORIGIN: INDIA


Manufactured by: WELABEL HEALTHCARE (INDIA)

E-Mail: info@welable.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

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
78020-333-012023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER
78020-333-022023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER
78020-333-032023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER
78020-333-062023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER
78020-333-082023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER
78020-333-162023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER
78020-333-342023-01-30C16284748780-1f386c649-cfbf-0266-e053-dadaa90a7c1aSTERITOUCH HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78020-333-01STERITOUCH HAND SANITIZER3785.41 mL in 1 BOTTLELIQUID3785.412
78020-333-02STERITOUCH HAND SANITIZER60 mL in 1 BOTTLELIQUID602
78020-333-03STERITOUCH HAND SANITIZER80 mL in 1 BOTTLELIQUID802
78020-333-06STERITOUCH HAND SANITIZER180 mL in 1 BOTTLELIQUID1802
78020-333-08STERITOUCH HAND SANITIZER236 mL in 1 BOTTLELIQUID2362
78020-333-16STERITOUCH HAND SANITIZER499.79 mL in 1 BOTTLELIQUID499.792
78020-333-34STERITOUCH HAND SANITIZER1005 mL in 1 BOTTLELIQUID10052

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78020-333STERITOUCH HAND SANITIZER (ALCOHOL) LIQUID [WELABLE HEALTHCARE]2Legacy NDC, 7 package rows20201105_6e0eba57-538f-433c-bcfd-74d7eb5b6685.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78020-33378020-333-01, 78020-333-02, 78020-333-08, 78020-333-34, 78020-333-16, 78020-333-06, 78020-333-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
fef792ec-0abe-426d-b9f3-d5368e8beda76e0eba57-538f-433c-bcfd-74d7eb5b66852020-11-03WarningsExact identifier
spl id: fef792ec-0abe-426d-b9f3-d5368e8beda7
spl set id: 6e0eba57-538f-433c-bcfd-74d7eb5b6685

Reported adverse events (FAERS/openFDA)#

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