FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
GUANGZHOU XUELEI COSMETIC CO.,LTD.
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:44:46

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure23 sections

Indications and uses

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

Dosage and administration

DISPENSE ONE PUMP OF SANITIZER ONTO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

Storage and handling

STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 74%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROMFIRE OR FLAME. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

STOP USE AND ASK DOCTOR IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN

72 HOURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DISPENSE ONE PUMP OF SANITIZER ONTO HANDS AND RUB TOGETHER UNTIL DRY. USE AS NEEDED. FOR CHILDREN UNDER 6, USE WITH ADULT SUPERVISION.

NOT RECOMMENDED FOR INFANTS.

OTHER INFO

STORAGE AND HANDLING SECTION

STORE BELOW 110 (DEGREES FAHRENHEIT). MAY CAUSE DISCOLORATION TO CERTAIN FABRICS AND SURFACES.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER ,CARBOMER , TRIETHANOLAMINE

KEEP OUT OF REACH OF CHILDREN

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.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (30ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

30ml e (1.0 fl.oz.)

NDC: 74658-002-01 30ml label30ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (60ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

60ml e (2.0 fl.oz.)

NDC: 74658-002-02 60ml label 160ml label 1 60ml label260ml label2

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (60ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

60ml e (2.0 fl.oz.)

NDC: 74658-002-03 60ml Tube Label60ml Tube Label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (70ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

70ml e (2.36 fl.oz.)

NDC: 74658-002-04 70ml label70ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (100ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

100ml e (3.4 fl.oz.)

NDC: 74658-002-05 100ml label 1100ml label 1 100ml label 2100ml label 2

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (120ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

120ml e (4.0 fl.oz.)

NDC: 74658-002-06 120ml label120ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (236ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

236ml e (8 fl.oz.)

NDC: 74658-002-07 236ml label236ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (250ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

250ml e (8.5 fl.oz.)

NDC: 74658-002-08 250ml label250ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (260ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

260ml e (8.8 fl.oz.)

NDC: 74658-002-09 260ml label260ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (290ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

290ml e (9.8 fl.oz.)

NDC: 74658-002-10 290ml label290ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (300ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

300ml e (10.2 fl.oz.)

NDC: 74658-002-11 300ml label300ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml e (17 fl.oz.)

NDC: 74658-002-12

500ml label500ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (950ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

950ml e (32.3 fl.oz.)

NDC: 74658-002-13 950ml label950ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (1000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

1000ml e (34 fl.oz.)

NDC: 74658-002-14 1000ml label1000ml label

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAND SANITIZER (2000ml)

SCENT FREE

SHIELD YOUR HANDS FROM GERMS AND INFECTION NATURALLY

KEEPS YOUR HANDS CLEAN & HYDRATED

2000ml e (68 fl.oz.)

NDC: 74658-002-15 2000ml label2000ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287762ethanol 74 % Topical GelPSN4
2287762ethanol 0.74 ML/ML Topical GelSCD4
2287762ethanol 74 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74658-002-012023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-022023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-032023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-042023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-052023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-062023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-072023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-082023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-092023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-102023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-112023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-122023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-132023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-142023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol
74658-002-152023-01-30C16284748780-1f386c649-c46c-0266-e053-dadaa90a7c1aHAND SANITIZER 74% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74658-002-01HAND SANITIZER30 mL in 1 BOTTLE, PLASTICGEL304
74658-002-02HAND SANITIZER60 mL in 1 BOTTLE, PLASTICGEL604
74658-002-03HAND SANITIZER60 mL in 1 TUBEGEL604
74658-002-04HAND SANITIZER70 mL in 1 BOTTLE, PLASTICGEL704
74658-002-05HAND SANITIZER100 mL in 1 BOTTLE, PLASTICGEL1004
74658-002-06HAND SANITIZER120 mL in 1 BOTTLE, PLASTICGEL1204
74658-002-07HAND SANITIZER236 mL in 1 BOTTLE, PLASTICGEL2364
74658-002-08HAND SANITIZER250 mL in 1 BOTTLE, PLASTICGEL2504
74658-002-09HAND SANITIZER260 mL in 1 BOTTLE, PLASTICGEL2604
74658-002-10HAND SANITIZER290 mL in 1 BOTTLE, PLASTICGEL2904
74658-002-11HAND SANITIZER300 mL in 1 BOTTLE, PLASTICGEL3004
74658-002-12HAND SANITIZER500 mL in 1 BOTTLE, PLASTICGEL5004
74658-002-13HAND SANITIZER950 mL in 1 BOTTLE, PLASTICGEL9504
74658-002-14HAND SANITIZER1000 mL in 1 BOTTLE, PLASTICGEL10004
74658-002-15HAND SANITIZER2000 mL in 1 BOTTLE, PLASTICGEL20004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74658-002HAND SANITIZER GEL [GUANGZHOU XUELEI COSMETIC CO.,LTD.]4Legacy NDC, 15 package rows20211106_a2e5db51-082b-1fc9-e053-2995a90aa6be.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74658-00274658-002-02, 74658-002-01, 74658-002-03, 74658-002-04, 74658-002-05, 74658-002-06, 74658-002-07, 74658-002-08, 74658-002-09, 74658-002-10, 74658-002-11, 74658-002-12, 74658-002-13, 74658-002-14, 74658-002-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

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
d001741b-9d60-73f7-e053-2995a90a6a34a2e5db51-082b-1fc9-e053-2995a90aa6be2021-11-04WarningsExact identifier
spl id: d001741b-9d60-73f7-e053-2995a90a6a34
spl set id: a2e5db51-082b-1fc9-e053-2995a90aa6be

Reported adverse events (FAERS/openFDA)#

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