FDA.reportPublic FDA data

75% ETHYL ALCOHOL HAND SANITIZER

Manufacturer
Bozhou Xunhetang Biological Technology Co., Ltd.
Effective date
2020-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:25

Label at a glance#

Product75% ETHYL ALCOHOL HAND SANITIZER
Active ingredientALCOHOL
Label structure13 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#

SPL UNCLASSIFIED SECTION

75% ETHYL ALCOHOL HAND SANITIZER

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, 75% ETHYL ALCOHOL HAND SANITIZER

Use

INDICATIONS & USAGE SECTION

75% ETHYL ALCOHOL 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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
CARBOMER
TRIETHANOLAMINE
ALOE ESSENCE
Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5050250250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN1
1047755ethanol 0.75 ML/ML Topical SolutionSCD1
1047755ethanol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78254-801-012022-01-28C16284748780-1d6a99b39-e0f5-a426-e053-dadaa90af4c275% ETHYL ALCOHOL HAND SANITIZER
78254-801-022022-01-28C16284748780-1d6a99b39-e0f5-a426-e053-dadaa90af4c275% ETHYL ALCOHOL HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78254-801-0175% ETHYL ALCOHOL HAND SANITIZER60 mL in 1 BOTTLELIQUID601
78254-801-0275% ETHYL ALCOHOL HAND SANITIZER250 mL in 1 BOTTLELIQUID2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78254-80175% ETHYL ALCOHOL HAND SANITIZER (ALCOHOL) LIQUID [BOZHOU XUNHETANG BIOLOGICAL TECHNOLOGY CO., LTD.]1Legacy NDC, 2 package rows20200901_ae270aac-54cf-3006-e053-2a95a90a32df.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
78254-80178254-801-01, 78254-801-02

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
ALOEV5VD430YW9IACT

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
ae270aac-54c1-3006-e053-2a95a90a32dfae270aac-54cf-3006-e053-2a95a90a32df2020-08-31WarningsExact identifier
spl id: ae270aac-54c1-3006-e053-2a95a90a32df
spl set id: ae270aac-54cf-3006-e053-2a95a90a32df

Reported adverse events (FAERS/openFDA)#

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