FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Guangzhou Oumiao Cosmetics Co. Ltd.
Effective date
2020-09-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:55

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Uses: Help reduce bacteria on skin

Dosage and administration

Directions : Thoroughly spread on hands and rub until dry Children under 6 years of age should be supervised when using this product

Storage and handling

Other Information : Store below 106'F ( 41C ) Distributed By Infinite Horizons International LLC , 16192 CoastalHighway Lewes , Delaware 19958 , County of Sussex , USA

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 75% Purpose : Antimicrobial

Purpose

OTC - PURPOSE SECTION

Purpose : Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Uses: Help reduce bacteria on skin

Warnings

WARNINGS SECTION

Warnings : Should be stored in a cool and dry place , away from fire .For external use only .

OTC - DO NOT USE SECTION

do not use in or near the eyes . In case of contact , rinse eyes thoroughly with water

When using this product

OTC - WHEN USING SECTION

When using this product , 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 reach for children

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash appears and lasts .

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach for children

Directions

DOSAGE & ADMINISTRATION SECTION

Directions : Thoroughly spread on hands and rub until dry Children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

Other Information : Store below 106'F ( 41C )

Distributed By Infinite Horizons International LLC , 16192 CoastalHighway Lewes , Delaware 19958 , County of Sussex , USA

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients : Aqua , Aroma , Carbomer , Peg-40Hydrogenated Castor Oil , Phenoxyethanol Triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74761-015-0174761-015-0174761-015-0274761-015-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74761-015-012022-01-28C16284748780-1d6a99b39-6248-a426-e053-dadaa90af4c274761-015 Hand Sanitizer
74761-015-022022-01-28C16284748780-1d6a99b39-6248-a426-e053-dadaa90af4c274761-015 Hand Sanitizer
74761-015-032022-01-28C16284748780-1d6a99b39-6248-a426-e053-dadaa90af4c274761-015 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74761-015-01Hand Sanitizer5 mL in 1 BOTTLEGEL52
74761-015-02Hand Sanitizer15 mL in 1 BOTTLEGEL152
74761-015-03Hand Sanitizer5 mL in 1 BAGGEL52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74761-015HAND SANITIZER GEL [GUANGZHOU OUMIAO COSMETICS CO. LTD. ]2Legacy NDC, 3 package rows20200923_afabe4fc-4451-d9c9-e053-2a95a90a0378.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74761-01574761-015-01, 74761-015-02, 74761-015-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
PEG-40 CASTOR OIL4ERD2076EFIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
afe3b5b9-2203-3e76-e053-2995a90ae606afabe4fc-4451-d9c9-e053-2a95a90a03782020-09-22WarningsExact identifier
spl id: afe3b5b9-2203-3e76-e053-2995a90ae606
spl set id: afabe4fc-4451-d9c9-e053-2a95a90a0378

Reported adverse events (FAERS/openFDA)#

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