Alcohol Antibacterial Gel(None-Rinse)

Manufacturer
Amicus Asia Pacific(Hubei) Healthcare Products Pte Ltd
Effective date
2020-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:00

Label at a glance#

ProductAlcohol Antibacterial Gel(None-Rinse)
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Store between 15- 30°C (59-86°F)

INACTIVE INGREDIENT SECTION

Purified Water USP, Triethanolamine,Carbomer,Glycerin

INDICATIONS & USAGE SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

OTC - ACTIVE INGREDIENT SECTION

Alcohol

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

OTC - PURPOSE SECTION

Disinfection
Sterilization
No Rinseing

WARNINGS SECTION

1.For extermal use only.
2.Do not use in children less than 2 months of age.
3.When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
4.Stop use and ask a doctor if iritation or rash occurs. This may be signs of a serious condition.
5.Keep out of reach of children. If swallowed, get medical help or contact a Posison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54345-002-012022-01-28C16284748780-1d6a99b39-dd9f-a426-e053-dadaa90af4c2a983fd02-a997-2466-e053-2a95a90a1a74

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54345-002-01Alcohol Antibacterial Gel(None-Rinse)80 mL in 1 BOTTLEGEL801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54345-002ALCOHOL ANTIBACTERIAL GEL(NONE-RINSE) (ALCOHOL) GEL [AMICUS ASIA PACIFIC(HUBEI) HEALTHCARE PRODUCTS PTE LTD]1Legacy NDC, 1 package rows20200703_a983fd02-a997-2466-e053-2a95a90a1a74.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54345-00254345-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
a983fd02-a998-2466-e053-2a95a90a1a74a983fd02-a997-2466-e053-2a95a90a1a742020-07-03WarningsExact identifier
spl id: a983fd02-a998-2466-e053-2a95a90a1a74
spl set id: a983fd02-a997-2466-e053-2a95a90a1a74

Reported adverse events (FAERS/openFDA)#

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