75% ALCOHOL DISINFECTANT

Manufacturer
Dongyang Medical & Hygienic Articles Co., Ltd.
Effective date
2020-12-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:58

Label at a glance#

Product75% ALCOHOL DISINFECTANT
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry. 2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 50C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic,Disinfection

Purpose

OTC - PURPOSE SECTION

Efficacy:

Efficient to kill Staphylococcus aureus,Escherichia coil,Pseudo monas aeruginosa and Candida alibicans etc.

Application:

Hand disinfection and general object surface disinfection.

Use

INDICATIONS & USAGE SECTION

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry.

2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

Warnings

WARNINGS SECTION

1.EXTREMELY FLAMMABLE:

seal preservation, keep away from sunlight perpendicular incidence place and don't expose to temperatures exceeds 50℃.Don't pierce or burn, even after use. Don't spray on a naked flame or any flammable material. Keep it away from the reach of children. Don't spray towards eyes.

2.External disinfectant should not be taken orally and kept out of reach of children.

3.Use with caution if allergic to alcohol.

4.It should not be used to disinfect fat-soluble surfaces.

5.This product is irritating to wounds and mucous membranes.

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

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry.

2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 50C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1L NDC: 81276-016-01

1 L label1 L label

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
81276-016-012022-01-28C16284748780-1d6a99b3a-01b4-a426-e053-dadaa90af4c281276-016 1L DONGYANG MEDICAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81276-016-0175% ALCOHOL DISINFECTANT1 L in 1 BOTTLELIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81276-01675% ALCOHOL DISINFECTANT LIQUID [DONGYANG MEDICAL & HYGIENIC ARTICLES CO., LTD.]1Legacy NDC, 1 package rows20201228_b77e7039-94c7-a554-e053-2a95a90aaa83.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
81276-01681276-016-01

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
b77e7039-94c8-a554-e053-2a95a90aaa83b77e7039-94c7-a554-e053-2a95a90aaa832020-12-27WarningsExact identifier
spl id: b77e7039-94c8-a554-e053-2a95a90aaa83
spl set id: b77e7039-94c7-a554-e053-2a95a90aaa83

Reported adverse events (FAERS/openFDA)#

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