FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD
Effective date
2020-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:08:05

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
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

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

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

WATER, PEG-40 CASTOR OIL, CARBOMER 940, TROLAMINE, CHLOROXYLENOL

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

480 ml NDC: 74913-668-09

480mL label480mL label

1000 ml NDC: 74913-668-10

1000mL label1000mL label

1200 ml NDC: 74913-668-11

1200mL label1200mL label

4000 ml NDC: 74913-668-12

4000mL label4000mL label

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
74913-668-092022-01-28C16284748780-1d6a99b39-f122-a426-e053-dadaa90af4c2a3d9c071-6c94-e62b-e053-2995a90ac1db
74913-668-102022-01-28C16284748780-1d6a99b39-f122-a426-e053-dadaa90af4c2a3d9c071-6c94-e62b-e053-2995a90ac1db
74913-668-112022-01-28C16284748780-1d6a99b39-f122-a426-e053-dadaa90af4c2a3d9c071-6c94-e62b-e053-2995a90ac1db
74913-668-122022-01-28C16284748780-1d6a99b39-f122-a426-e053-dadaa90af4c2a3d9c071-6c94-e62b-e053-2995a90ac1db

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74913-668-09Hand Sanitizer480 mL in 1 BOTTLE, PLASTICGEL4802
74913-668-10Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10002
74913-668-11Hand Sanitizer1200 mL in 1 BOTTLE, PLASTICGEL12002
74913-668-12Hand Sanitizer4000 mL in 1 BOTTLE, PLASTICGEL40002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74913-668HAND SANITIZER (ALCOHOL) GEL [SHANTOU S.E.Z BAOJIE INDUSTRY CO., LTD]2Legacy NDC, 4 package rows20200427_a3d9c071-6c94-e62b-e053-2995a90ac1db.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
74913-66874913-668-09, 74913-668-10, 74913-668-11, 74913-668-12

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
CHLOROXYLENOL0F32U78V2QIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT

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
a42eedd3-466d-7c4d-e053-2995a90aabf4a3d9c071-6c94-e62b-e053-2995a90ac1db2020-04-26WarningsExact identifier
spl id: a42eedd3-466d-7c4d-e053-2995a90aabf4
spl set id: a3d9c071-6c94-e62b-e053-2995a90ac1db

Reported adverse events (FAERS/openFDA)#

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