FDA.reportPublic FDA data

Hands free disinfectant

Manufacturer
Jiangxi Langhong Industry Co., Ltd.
Effective date
2020-04-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:06:34

Label at a glance#

ProductHands free disinfectant
Active ingredientALCOHOL
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

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. Glycerol
  3. CARBOMER INTERPOLYMER TYPE A (55000 CPS)
  4. TRIETHANOLAMINE
  5. METHYL BENZOATE
  6. 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

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

GLYCERIN
WATER
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
TRIETHANOLAMINE
METHYL BENZOATE

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL NDC:74463-101-01

60 mL NDC:74463-101-02

100 mL NDC:74463-101-03

250 mL NDC:74463-101-04

300 mL NDC:74463-101-05

1000 mL NDC:74463-101-06

5000 mL NDC:74463-101-07

10000 mL NDC:74463-101-08

20000 mL NDC:74463-101-09

950 mL NDC:74463-101-10

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74463-101-012021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-022021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-032021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-042021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-052021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-062021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-072021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-082021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-092021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant
74463-101-102021-07-23C16284748780-1c7ccaba7-25bc-fd44-e053-dadaa90aa01bHands free disinfectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74463-101-01Hands free disinfectant50 mL in 1 BOTTLELIQUID502
74463-101-02Hands free disinfectant60 mL in 1 BOTTLELIQUID602
74463-101-03Hands free disinfectant100 mL in 1 BOTTLELIQUID1002
74463-101-04Hands free disinfectant250 mL in 1 BOTTLELIQUID2502
74463-101-05Hands free disinfectant300 mL in 1 BOTTLELIQUID3002
74463-101-06Hands free disinfectant1000 mL in 1 BOTTLELIQUID10002
74463-101-07Hands free disinfectant5000 mL in 1 BOTTLELIQUID50002
74463-101-08Hands free disinfectant100000 mL in 1 BOTTLELIQUID1000002
74463-101-09Hands free disinfectant200000 mL in 1 BOTTLELIQUID2000002
74463-101-10Hands free disinfectant950 mL in 1 BOTTLELIQUID9502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74463-101HANDS FREE DISINFECTANT (ALCOHOL) LIQUID [JIANGXI LANGHONG INDUSTRY CO., LTD.]2Legacy NDC, 10 package rows20200417_a2ca5d9d-75af-3f50-e053-2995a90a56ed.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74463-10174463-101-01, 74463-101-02, 74463-101-03, 74463-101-04, 74463-101-05, 74463-101-06, 74463-101-07, 74463-101-08, 74463-101-09, 74463-101-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
METHYL BENZOATE6618K1VJ9TIACT

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
a36a63cd-915d-7b9d-e053-2a95a90ae690a2ca5d9d-75af-3f50-e053-2995a90a56ed2020-04-16WarningsExact identifier
spl id: a36a63cd-915d-7b9d-e053-2a95a90ae690
spl set id: a2ca5d9d-75af-3f50-e053-2995a90a56ed

Reported adverse events (FAERS/openFDA)#

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