FDA.reportPublic FDA data

70% ISOPROPLYL ALCOHOL

Manufacturer
Zhongrong Technology Corporation Ltd.
Effective date
2022-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:40

Label at a glance#

Product70% ISOPROPLYL ALCOHOL
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Dosage and administration

Simply put on hands or general surface and rub until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

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

Isopropyl Alcohol 70% v/v. Purpose: Disinfection

Purpose

OTC - PURPOSE SECTION

Disinfection, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To help eliminate bacteria on the skin or general surface that may cause disease anytime and anywhere.

Warnings

WARNINGS SECTION

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

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

  • Simply put on hands or general surface and rub until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

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

Purified water

RECENT MAJOR CHANGES SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 ml NDC: 81191-004-01 500ml500ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN2
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD2
808520isopropyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81191-004-012023-07-28C16284748780-10191ceaa-7272-198a-e063-dbdaa90aec3e70% ISOPROPYL ALCOHOL
81191-004-022023-07-28C16284748780-10191ceaa-7272-198a-e063-dbdaa90aec3e70% ISOPROPYL ALCOHOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81191-004-0170% ISOPROPLYL ALCOHOL500 mL in 1 BOTTLELIQUID5002
81191-004-0270% ISOPROPLYL ALCOHOL3785 mL in 1 BOTTLELIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81191-00470% ISOPROPLYL ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [ZHONGRONG TECHNOLOGY CORPORATION LTD.]2Legacy NDC, 2 package rows20220310_d302f4f4-0a79-7064-e053-2995a90a01a8.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
81191-00481191-004-01, 81191-004-02

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
ISOPROPYL ALCOHOLND2M416302ACTIB

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
d9d9b396-10bf-388d-e053-2995a90a2c3cd302f4f4-0a79-7064-e053-2995a90a01a82022-03-10WarningsExact identifier
spl id: d9d9b396-10bf-388d-e053-2995a90a2c3c
spl set id: d302f4f4-0a79-7064-e053-2995a90a01a8

Reported adverse events (FAERS/openFDA)#

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