Hand Sanitizer

Manufacturer
Jiangsu Doer biotechnology Co., Ltd
Effective date
2021-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:36

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Directions: clean affected area. apply small amount of this product on the area 1-3 times dailly. if bandaged let dry first. may be covered with a sterile bandage.

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

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. Isopropyl Alcohol (75%, 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

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

USE: for disinfection, sterilization. relief of prockly heat. insect bites, hygenic purposes and general antiseptic.

Warnings

WARNINGS SECTION

For external use only. if taken internally serious gasric disturbances will result.

Flammable. Keep away from heat or flame. Use only in a well-ventilated area; fumes may be toxic.

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. Keep out reach of children.

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

Directions:

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

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946 ml NDC:55449-075-01

946 ml label946 ml 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
55449-946-012023-01-30C16284748780-1f386c64a-4846-0266-e053-dadaa90a7c1aHand Sanitizer 55449-075-01 500ml 55449-075-02 946ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55449-946-01Hand Sanitizer946 mL in 1 BOTTLELIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55449-946HAND SANITIZER (75% ALCOHOL ) LIQUID [JIANGSU DOER BIOTECHNOLOGY CO., LTD]1Legacy NDC, 1 package rows20211030_cf7ef2ef-ade3-cf92-e053-2995a90ae66d.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55449-94655449-946-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
cf7ef2ef-ade2-cf92-e053-2995a90ae66dcf7ef2ef-ade3-cf92-e053-2995a90ae66d2021-10-29WarningsExact identifier
spl id: cf7ef2ef-ade2-cf92-e053-2995a90ae66d
spl set id: cf7ef2ef-ade3-cf92-e053-2995a90ae66d

Reported adverse events (FAERS/openFDA)#

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