FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Manufacturer
Shanghai Rayshine ENVI-TECH Developing CO., Ltd.
Effective date
2020-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:32

Label at a glance#

ProductAntibacterial Hand Sanitizer
Active ingredientGLUTARAL, CARBONIC ANHYDRASE 1
Label structure8 sections

Indications and uses

For hand sanitizing to reduce bacteria on the skin.

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glutaraldehyde 0.3%, AES 7.0%, APG 1.0%, AEO-9 0.5%, CAB 3.8%

Purpose

OTC - PURPOSE SECTION


Antibacterial

Uses

INDICATIONS & USAGE SECTION


For hand sanitizing to reduce bacteria on the skin.

Warnings

WARNINGS SECTION


For extermal use only-hands. Flamable. Keep aways from heat and flame.

Do not use

OTC - DO NOT USE SECTION


in children less than 2 months of ageon open skin wounds

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Salt, Citric Acid

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11223344

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75129-002-012021-07-23C16284748780-1c7ccaba7-16fb-fd44-e053-dadaa90aa01bAntibacterial Hand Sanitizer
75129-002-022021-07-23C16284748780-1c7ccaba7-16fb-fd44-e053-dadaa90aa01bAntibacterial Hand Sanitizer
75129-002-032021-07-23C16284748780-1c7ccaba7-16fb-fd44-e053-dadaa90aa01bAntibacterial Hand Sanitizer
75129-002-042021-07-23C16284748780-1c7ccaba7-16fb-fd44-e053-dadaa90aa01bAntibacterial Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75129-002-01Antibacterial Hand Sanitizer300 mL in 1 BOTTLEGEL3001
75129-002-02Antibacterial Hand Sanitizer500 mL in 1 BOTTLEGEL5001
75129-002-03Antibacterial Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
75129-002-04Antibacterial Hand Sanitizer5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75129-002ANTIBACTERIAL HAND SANITIZER GEL [SHANGHAI RAYSHINE ENVI-TECH DEVELOPING CO., LTD.]1Legacy NDC, 4 package rows20200505_a38d64df-ffd5-f721-e053-2995a90a2ed8.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
75129-00275129-002-01, 75129-002-02, 75129-002-03, 75129-002-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLUTARALT3C89M417NACTIB
SODIUM CHLORIDE451W47IQ8XIACT
CARBONIC ANHYDRASE 131F7ZV0E20ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
a38d5aa0-5c09-3548-e053-2995a90ace32a38d64df-ffd5-f721-e053-2995a90a2ed82020-04-18WarningsExact identifier
spl id: a38d5aa0-5c09-3548-e053-2995a90ace32
spl set id: a38d64df-ffd5-f721-e053-2995a90a2ed8

Reported adverse events (FAERS/openFDA)#

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