FDA.reportPublic FDA data

75605-008 HAND SANITIZER NON-STERILE SOLUTION

Manufacturer
Guangzhou Shiruoni Cosmetics Co.,Ltd
Effective date
2020-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:47

Label at a glance#

ProductHAND SANITIZER NON-STERILE
Active ingredientISOPROPYL ALCOHOL
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 15-30C(59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not avallable.

WARNING

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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

deionized water, aloe barbadensis extract, carbomer, arginine, silver ions

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75605-008-02 252ml75605-008-02 252ml75605-008-01 60ml75605-008-01 60ml75605-008-04 500ml75605-008-04 500ml75605-008-03 355ml75605-008-03 355ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD1
1039900isopropyl alcohol 75 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75605-008-012022-01-28C16284748780-1d6a99b39-6135-a426-e053-dadaa90af4c275605-008 HAND SANITIZER NON-STERILE SOLUTION
75605-008-022022-01-28C16284748780-1d6a99b39-6135-a426-e053-dadaa90af4c275605-008 HAND SANITIZER NON-STERILE SOLUTION
75605-008-032022-01-28C16284748780-1d6a99b39-6135-a426-e053-dadaa90af4c275605-008 HAND SANITIZER NON-STERILE SOLUTION
75605-008-042022-01-28C16284748780-1d6a99b39-6135-a426-e053-dadaa90af4c275605-008 HAND SANITIZER NON-STERILE SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75605-008-01HAND SANITIZER NON-STERILE60 mL in 1 BOTTLESOLUTION601
75605-008-02HAND SANITIZER NON-STERILE252 mL in 1 BOTTLESOLUTION2521
75605-008-03HAND SANITIZER NON-STERILE355 mL in 1 BOTTLESOLUTION3551
75605-008-04HAND SANITIZER NON-STERILE500 mL in 1 BOTTLESOLUTION5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75605-008HAND SANITIZER NON-STERILE SOLUTION [GUANGZHOU SHIRUONI COSMETICS CO.,LTD]1Legacy NDC, 4 package rows20200904_adebaadf-8a7e-1a51-e053-2995a90a381a.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
75605-00875605-008-03, 75605-008-01, 75605-008-02, 75605-008-04

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
ARGININE94ZLA3W45FIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
SILVER CATION57N7B0K90AIACT

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
adeaad60-8e5f-7482-e053-2995a90ac688adebaadf-8a7e-1a51-e053-2995a90a381a2020-08-28WarningsExact identifier
spl id: adeaad60-8e5f-7482-e053-2995a90ac688
spl set id: adebaadf-8a7e-1a51-e053-2995a90a381a

Reported adverse events (FAERS/openFDA)#

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