FDA.reportPublic FDA data

75% MEDICAL ALCOHOL

Manufacturer
Xinxiang Xianfeng Medicine New Material Co., Ltd.
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:32

Label at a glance#

Product75% MEDICAL ALCOHOL
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Perennial exposure to high concentrations of this product can cause irritation of the nose, eyes, and mucous membranes as well as headache, dizziness, fatigue, irritability, tremor, nausea, etc.

Storage and handling

The temperature of the warehouse should not exceed 30℃, keep the container seal

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethanol 75%(V/V)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Used to kill Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and other microorganisms.

Warnings

WARNINGS SECTION

[Matters needing attention]
1.This product is for external use and should not be taken orally;
2.This product should be kept out of the reach of children;
3.This product is flammable and should be kept away from sources of ignition

[Taboo]
This product is not suitable for disinfecting the surface off at-soluble objects, and should be used with caution for those who are allergic to alcohol.

Do not use

OTC - DO NOT USE SECTION

/

OTC - WHEN USING SECTION

1.It is suitable for disinfection of the surface of objects and the surface of human skin.
2.Take this product to wipe the surface of objects or the surface of human skin directly.Or use a medical cotton swab(or cotton ball) dipped in a little product to wipe.Act just for three minutes.

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

/

Directions

DOSAGE & ADMINISTRATION SECTION

Perennial exposure to high concentrations of this product can cause irritation of the nose, eyes, and mucous membranes as well as headache, dizziness, fatigue, irritability, tremor, nausea, etc.

Other information

STORAGE AND HANDLING SECTION

The temperature of the warehouse should not exceed 30℃, keep the container seal

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water 25%(V/V)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE 80874-001-01 0.085kg

BOTTLE 80874-001-01 0.085kgBOTTLE 80874-001-01 0.085kg

BOTTLE 80874-001-02 0.085kg BOTTLE 80874-001-02 0.085kgBOTTLE 80874-001-02 0.085kg

BOTTLE 80874-001-03 0.425kg

BOTTLE 80874-001-03 0.425kgBOTTLE 80874-001-03 0.425kg

DRUM 80874-001-04 20kg

DRUM 80874-001-04 20kgDRUM 80874-001-04 20kg

DRUM 80874-001-05 165kg

DRUM 80874-001-05 165kgDRUM 80874-001-05 165kg

DRUM 80874-001-06 800kg

DRUM 80874-001-06 800kgDRUM 80874-001-06 800kg

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
80874-001-012022-01-28C16284748780-1d6a99b39-ce99-a426-e053-dadaa90af4c280874-001 75% MEDICAL ALCOHOL
80874-001-022022-01-28C16284748780-1d6a99b39-ce99-a426-e053-dadaa90af4c280874-001 75% MEDICAL ALCOHOL
80874-001-032022-01-28C16284748780-1d6a99b39-ce99-a426-e053-dadaa90af4c280874-001 75% MEDICAL ALCOHOL
80874-001-042022-01-28C16284748780-1d6a99b39-ce99-a426-e053-dadaa90af4c280874-001 75% MEDICAL ALCOHOL
80874-001-052022-01-28C16284748780-1d6a99b39-ce99-a426-e053-dadaa90af4c280874-001 75% MEDICAL ALCOHOL
80874-001-062022-01-28C16284748780-1d6a99b39-ce99-a426-e053-dadaa90af4c280874-001 75% MEDICAL ALCOHOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80874-001-0175% MEDICAL ALCOHOL0.085 kg in 1 BOTTLELIQUID0.0851
80874-001-0275% MEDICAL ALCOHOL0.085 kg in 1 BOTTLELIQUID0.0851
80874-001-0375% MEDICAL ALCOHOL0.425 kg in 1 BOTTLELIQUID0.4251
80874-001-0475% MEDICAL ALCOHOL20 kg in 1 DRUMLIQUID201
80874-001-0575% MEDICAL ALCOHOL165 kg in 1 DRUMLIQUID1651
80874-001-0675% MEDICAL ALCOHOL800 kg in 1 DRUMLIQUID8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80874-00175% MEDICAL ALCOHOL LIQUID [XINXIANG XIANFENG MEDICINE NEW MATERIAL CO., LTD.]1Legacy NDC, 6 package rows20201218_b6b3d50c-7171-2ab2-e053-2a95a90aa3f4.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80874-00180874-001-01, 80874-001-02, 80874-001-04, 80874-001-05, 80874-001-03, 80874-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
b6b3d50c-7161-2ab2-e053-2a95a90aa3f4b6b3d50c-7171-2ab2-e053-2a95a90aa3f42020-12-17WarningsExact identifier
spl id: b6b3d50c-7161-2ab2-e053-2a95a90aa3f4
spl set id: b6b3d50c-7171-2ab2-e053-2a95a90aa3f4

Reported adverse events (FAERS/openFDA)#

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