FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
Shantou Wanli Biotechnology Co.,Ltd.
Effective date
2020-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:41

Label at a glance#

ProductHand Sanitizer Gel
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 15-30°C (59-86F) Avoid freezing and excessive heat above 40°C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alchohol 75%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30302362366060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74928-003-012022-01-28C16284748780-1d6a99b39-5c56-a426-e053-dadaa90af4c2Hand Sanitizer Gel
74928-003-022022-01-28C16284748780-1d6a99b39-5c56-a426-e053-dadaa90af4c2Hand Sanitizer Gel
74928-003-032022-01-28C16284748780-1d6a99b39-5c56-a426-e053-dadaa90af4c2Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74928-003-01Hand Sanitizer Gel30 mL in 1 BOTTLEGEL301
74928-003-02Hand Sanitizer Gel60 mL in 1 BOTTLEGEL601
74928-003-03Hand Sanitizer Gel236 mL in 1 BOTTLEGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74928-003HAND SANITIZER GEL GEL [SHANTOU WANLI BIOTECHNOLOGY CO.,LTD.]1Legacy NDC, 3 package rows20200709_a9f98893-7de7-d37c-e053-2995a90abbb4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74928-00374928-003-03, 74928-003-02, 74928-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 1342809Y72KV36IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
DENATONIUM BENZOATE4YK5Z54AT2IACT
TROLAMINE9O3K93S3TKIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT

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
a9f9b1af-d685-fabb-e053-2995a90accfda9f98893-7de7-d37c-e053-2995a90abbb42020-07-08WarningsExact identifier
spl id: a9f9b1af-d685-fabb-e053-2995a90accfd
spl set id: a9f98893-7de7-d37c-e053-2995a90abbb4

Reported adverse events (FAERS/openFDA)#

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