Alcohol Disinfectant

Manufacturer
Qingdao Maixing Biotechnology Co.,Ltd
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:08:15

Label at a glance#

ProductAlcohol Disinfectant
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

this product is for extermal use.apply this product to skin,hands and general objects this product is not a substitute for drugs or medical devices use with caution;infants, pregnant women and breastfeeding women keep out of reach of children, do not use on children 6 years old.do not use on open skin wounds

Storage and handling

do not store above 105.F may discolor some fabrics harmful to wood finisher and plastics

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) (75%, 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. 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: disinfection and antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

purpose:disinfection and antiseptic

Use

INDICATIONS & USAGE SECTION

Suitable for sterilization and disinfection of the surface of the object and the complete skin of the human body.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • do not use on children 6 years old.
  • do not use on open skin wounds

OTC - WHEN USING SECTION

Keep out of eyes.in case of contact with eyes,flush thoroughly with water.

Avoid contact with broken skin.

Do not inhale or ingest.

OTC - STOP USE SECTION

stop use and ask a doctor if irritation and redness develop,condition persists for more tahn 72 hours

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

this product is for extermal use.apply this product to skin,hands and general objects
this product is not a substitute for drugs or medical devices
use with caution;infants, pregnant women and breastfeeding women
keep out of reach of children,
do not use on children 6 years old.do not use on open skin wounds

Other information

STORAGE AND HANDLING SECTION

  • do not store above 105.F
  • may discolor some fabrics
  • harmful to wood finisher and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC: 75711-003-0175711-003-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1047755ethanol 75 % Topical SolutionPSN3
1047755ethanol 0.75 ML/ML Topical SolutionSCD3
1047755ethanol 75 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75711-003-012022-01-28C16284748780-1d6a99b39-a43f-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75711-003-01Alcohol Disinfectant50 mL in 1 BOTTLELIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75711-003ALCOHOL DISINFECTANT (ALCOHOL) LIQUID [QINGDAO MAIXING BIOTECHNOLOGY CO.,LTD]3Legacy NDC, 1 package rows20200428_a3c7969b-0f64-6aea-e053-2995a90a7679.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
75711-00375711-003-01

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 · Source PDF

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
a4414e2a-4aa9-718c-e053-2995a90a7217a3c7969b-0f64-6aea-e053-2995a90a76792020-04-22WarningsExact identifier
spl id: a4414e2a-4aa9-718c-e053-2995a90a7217
spl set id: a3c7969b-0f64-6aea-e053-2995a90a7679

Reported adverse events (FAERS/openFDA)#

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