FDA.reportPublic FDA data

Disinfectant

Manufacturer
Shanghai Qunli Enterprise (Group) Co., Ltd.
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:32

Label at a glance#

ProductDisinfectant
Active ingredientHYPOCHLOROUS ACID
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together 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

The disinfectant is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (50%, 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. HYPOCHLOROUS ACID
  3. 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

HYPOCHLOROUS ACID 1mg/100mL

Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

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

  • Place enough product on hands to cover all surfaces. Rub hands together 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

ALCOHOL
WATER

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL NDC: 74524-101-01

30 mL NDC: 74524-101-02

60 mL NDC: 74524-101-03

100 mL NDC: 74524-101-04

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74524-101-012021-07-23C16284748780-1c7ccaba7-250b-fd44-e053-dadaa90aa01bDisinfectant
74524-101-022021-07-23C16284748780-1c7ccaba7-250b-fd44-e053-dadaa90aa01bDisinfectant
74524-101-032021-07-23C16284748780-1c7ccaba7-250b-fd44-e053-dadaa90aa01bDisinfectant
74524-101-042021-07-23C16284748780-1c7ccaba7-250b-fd44-e053-dadaa90aa01bDisinfectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74524-101-01Disinfectant15 mL in 1 BOTTLELIQUID151
74524-101-02Disinfectant30 mL in 1 BOTTLELIQUID301
74524-101-03Disinfectant60 mL in 1 BOTTLELIQUID601
74524-101-04Disinfectant100 mL in 1 BOTTLELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74524-101DISINFECTANT (HYPOCHLOROUS ACID) LIQUID [SHANGHAI QUNLI ENTERPRISE (GROUP) CO., LTD.]1Legacy NDC, 4 package rows20200409_a2cba50b-d5fa-9cd5-e053-2a95a90a58f0.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74524-10174524-101-01, 74524-101-02, 74524-101-03, 74524-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
HYPOCHLOROUS ACID712K4CDC10ACTIB

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
a2cba50b-d5fb-9cd5-e053-2a95a90a58f0a2cba50b-d5fa-9cd5-e053-2a95a90a58f02020-04-08WarningsExact identifier
spl id: a2cba50b-d5fb-9cd5-e053-2a95a90a58f0
spl set id: a2cba50b-d5fa-9cd5-e053-2a95a90a58f0

Reported adverse events (FAERS/openFDA)#

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