FDA.reportPublic FDA data

ANTIBACTERIAL Hand Sanitizer

Manufacturer
Guangzhou Dedo Pharmaceutical Co.,Ltd
Effective date
2020-04-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:07:36

Label at a glance#

ProductANTIBACTERIAL Hand Sanitizer
Active ingredientALCOHOL, CHLOROXYLENOL
Label structure9 sections

Dosage and administration

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry. Children under 6 years of age should be supervised when using this product.

Storage and handling

Please keep it in a cool and ventilated place.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Parachlormetaxylenol-0.13%.Ethanol 24%.

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

it is suitable for dally bacteriostasis of hand,Bacleriostasis,sterillzation.wash-free.Contain antibacterial components, effectively inhibit staphylococcus aureus and escherichia.coli;

Warnings

WARNINGS SECTION

for external use only.

OTC - WHEN USING SECTION

do not use in or near the eyes.In case of contact.rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts.

Keep out of teach for children.

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough Product in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

Please keep it in a cool and ventilated place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water(Aqua).Carbomer.Triethanolamine,DMDM hydantoin,PEG-40 hydrogenated castor oil, Essence.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LAbelLAbel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74534-011-012022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-022022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-032022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-042022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-052022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-062022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-072022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-082022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-092022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-102022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-112022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-122022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-132022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-142022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-152022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-162022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547
74534-011-172022-01-28C16284748780-1d6a99b39-f069-a426-e053-dadaa90af4c2a3006349-bd4d-59a6-e053-2a95a90a7547

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74534-011-01ANTIBACTERIAL Hand Sanitizer500 g in 1 BOTTLELIQUID5003
74534-011-02ANTIBACTERIAL Hand Sanitizer300 g in 1 BOTTLELIQUID3003
74534-011-03ANTIBACTERIAL Hand Sanitizer200 g in 1 BOTTLELIQUID2003
74534-011-04ANTIBACTERIAL Hand Sanitizer100 g in 1 BOTTLELIQUID1003
74534-011-05ANTIBACTERIAL Hand Sanitizer50 g in 1 BOTTLELIQUID503
74534-011-06ANTIBACTERIAL Hand Sanitizer30 g in 1 BOTTLELIQUID303
74534-011-07ANTIBACTERIAL Hand Sanitizer35 g in 1 BOTTLELIQUID353
74534-011-08ANTIBACTERIAL Hand Sanitizer60 g in 1 BOTTLELIQUID603
74534-011-09ANTIBACTERIAL Hand Sanitizer75 g in 1 BOTTLELIQUID753
74534-011-10ANTIBACTERIAL Hand Sanitizer1000000 g in 1 BOTTLELIQUID10000003
74534-011-11ANTIBACTERIAL Hand Sanitizer100000 g in 1 BOTTLELIQUID1000003
74534-011-12ANTIBACTERIAL Hand Sanitizer50000 g in 1 BOTTLELIQUID500003
74534-011-13ANTIBACTERIAL Hand Sanitizer5000 g in 1 BOTTLELIQUID50003
74534-011-14ANTIBACTERIAL Hand Sanitizer2000 g in 1 BOTTLELIQUID20003
74534-011-15ANTIBACTERIAL Hand Sanitizer1000 g in 1 BOTTLELIQUID10003
74534-011-16ANTIBACTERIAL Hand Sanitizer250 g in 1 BOTTLELIQUID2503
74534-011-17ANTIBACTERIAL Hand Sanitizer80 g in 1 BOTTLELIQUID803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74534-011ANTIBACTERIAL HAND SANITIZER LIQUID [GUANGZHOU DEDO PHARMACEUTICAL CO.,LTD]3Legacy NDC, 17 package rows20200424_a3006349-bd4d-59a6-e053-2a95a90a7547.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
74534-01174534-011-01, 74534-011-12, 74534-011-15, 74534-011-02, 74534-011-16, 74534-011-03, 74534-011-17, 74534-011-04, 74534-011-05, 74534-011-07, 74534-011-06, 74534-011-08, 74534-011-13, 74534-011-09, 74534-011-10, 74534-011-11, 74534-011-14

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 HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALCOHOL3K9958V90MACTIB
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
CHLOROXYLENOL0F32U78V2QACTIB
TROLAMINE9O3K93S3TKIACT
DMDM HYDANTOINBYR0546TOWIACT

Source Document#

Source XML · Source PDF

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
a400e2b5-042d-5aab-e053-2995a90a16b7a3006349-bd4d-59a6-e053-2a95a90a75472020-04-23WarningsExact identifier
spl id: a400e2b5-042d-5aab-e053-2995a90a16b7
spl set id: a3006349-bd4d-59a6-e053-2a95a90a7547

Reported adverse events (FAERS/openFDA)#

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