FDA.reportPublic FDA data

DISINFECTANT ALCOHOL

Manufacturer
Jiangsu Doer biotechnology Co., Ltd
Effective date
2020-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:04

Label at a glance#

ProductDISINFECTANT ALCOHOL
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

dean affected area apply small amount of this product on the area 1-3 times daily if bandaged, let dry first may be covered with a sterile bandage

Storage and handling

store at room temperature does not contain, nor is intended as a substitute for grain or ethyl alcohol

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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, DISINFECTANT ALCOHOL

Use

INDICATIONS & USAGE SECTION

fist aid to help prevent prevent the risk of infection in minor cuts, scrapes, and burms.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

  • do not get into eyes.
  • do not apply over large areas of the body.
  • do not use longer than one week unless directed by a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists or gets worse.

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

  • dean affected area
    • apply small amount of this product on the area 1-3 times daily
    • if bandaged, let dry first
    • may be covered with a sterile bandage

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 55449-005

3800 ml label3800 ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55449-005-012022-01-28C16284748780-1d6a99b39-79b9-a426-e053-dadaa90af4c255449-05-01 02 03 DISINFECTANT ALCOHOL
55449-005-022022-01-28C16284748780-1d6a99b39-79b9-a426-e053-dadaa90af4c255449-05-01 02 03 DISINFECTANT ALCOHOL
55449-005-032022-01-28C16284748780-1d6a99b39-79b9-a426-e053-dadaa90af4c255449-05-01 02 03 DISINFECTANT ALCOHOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55449-005-01DISINFECTANT ALCOHOL3800 mL in 1 BOTTLELIQUID38001
55449-005-02DISINFECTANT ALCOHOL500 mL in 1 BOTTLELIQUID5001
55449-005-03DISINFECTANT ALCOHOL100 mL in 1 BOTTLELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55449-005DISINFECTANT ALCOHOL LIQUID [JIANGSU DOER BIOTECHNOLOGY CO., LTD]1Legacy NDC, 3 package rows20200828_add4bb6b-a243-eff6-e053-2995a90aea08.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
55449-00555449-005-01, 55449-005-02, 55449-005-03

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
add4badd-acbb-cebf-e053-2995a90a6ae1add4bb6b-a243-eff6-e053-2995a90aea082020-08-26WarningsExact identifier
spl id: add4badd-acbb-cebf-e053-2995a90a6ae1
spl set id: add4bb6b-a243-eff6-e053-2995a90aea08

Reported adverse events (FAERS/openFDA)#

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