FDA.reportPublic FDA data

Wash-Free Surgical Hand Disinfectant Gel II

Manufacturer
Shan Dong Lircon Medical Technology Co., Ltd
Effective date
2021-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:19

Label at a glance#

ProductWash-Free Surgical Hand Disinfectant Gel II
Active ingredientALCOHOL
Label structure13 sections

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Disinfectant type

SPL UNCLASSIFIED SECTION

Antiseptic, Hand Sanitizer

Major ingredient and concentration

OTC - ACTIVE INGREDIENT SECTION

This product is a disinfectant gel with ethanol as the main active ingredient, and the ethanol content is 75%±7.5% v/v. Add skin care ingredients such as moisturizers and moisturizers.

Germicidal spectrum

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer. It can kill the microorganisms such as enter ic pathogenic bacteria, pyogenic coccus, pathogenic yeast and hospital infect ion common germs.

Application soope

INDICATIONS & USAGE SECTION

1. Sanitary hand disinfeotion: suitable for hand disinfeotion of medical staff in out patient。linios, wards, emergency room. intensive care units，hemodialysis rooms, and endoscopy rooms of medical and health institutions. It is suitable for quick
disinfeotion of hands of persons who need to perform hand hygiene.

2. Surgical hand disinfection: suitable for preoperative surgical hand disinfection in the operating room of medical and health inst itutions.

Cautions

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.

Usage

DOSAGE & ADMINISTRATION SECTION

Sanitary hand disinfection: Take an appropriate amount of disinfectant gel (2-3ml) on the palm, rub your hands together to make it evenly spread on each part (ensure that the liquid covers the entire surface), Follow the WS/T313 "Specification of hand hygiene for health care workers
" Appendix A, the method of hand washing for medical workers, rub and disinfect for 1 minute.

Surgical hand disinfection：1. Wash hands and forearms, rinse thoroughly and dry. 2. Take an appropriate amount of disinfectant gel (5-10ml), follow the WS/T313 "Specification of hand hygiene for health care workers " Appendix C Surgical no-wash disinfection method, rub your hands and forearms to the lower third of the upper arms for 3 minutes.Wear sterile gloves after drying.

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

carbomer, triethanolamine, glycerol, purified water.

package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label is attached81630-002-0181630-002-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2367439ethanol 64.8 % Topical GelPSN1
2367439ethanol 0.648 ML/ML Topical GelSCD1
2367439ethanol 64.8 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81630-002-032023-01-30C16284748780-1f386c649-aea2-0266-e053-dadaa90a7c1aSPL file for drug listing
81630-002-052023-01-30C16284748780-1f386c649-aea2-0266-e053-dadaa90a7c1aSPL file for drug listing
81630-002-072023-01-30C16284748780-1f386c649-aea2-0266-e053-dadaa90a7c1aSPL file for drug listing
81630-002-092023-01-30C16284748780-1f386c649-aea2-0266-e053-dadaa90a7c1aSPL file for drug listing
81630-002-112023-01-30C16284748780-1f386c649-aea2-0266-e053-dadaa90a7c1aSPL file for drug listing
81630-002-132023-01-30C16284748780-1f386c649-aea2-0266-e053-dadaa90a7c1aSPL file for drug listing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81630-002-01Wash-Free Surgical Hand Disinfectant Gel II60 mL in 1 BOTTLE, PLASTICGEL601
81630-002-02Wash-Free Surgical Hand Disinfectant Gel II10 in 1 BOXGEL101
81630-002-03Wash-Free Surgical Hand Disinfectant Gel II10 in 1 BOXGEL101
81630-002-04Wash-Free Surgical Hand Disinfectant Gel II248 mL in 1 BOTTLE, PLASTICGEL2481
81630-002-05Wash-Free Surgical Hand Disinfectant Gel II40 in 1 BOXGEL401
81630-002-06Wash-Free Surgical Hand Disinfectant Gel II500 mL in 1 BOTTLE, PLASTICGEL5001
81630-002-07Wash-Free Surgical Hand Disinfectant Gel II25 in 1 BOXGEL251
81630-002-08Wash-Free Surgical Hand Disinfectant Gel II1000 mL in 1 BOTTLE, PLASTICGEL10001
81630-002-09Wash-Free Surgical Hand Disinfectant Gel II16 in 1 BOXGEL161
81630-002-10Wash-Free Surgical Hand Disinfectant Gel II1000 mL in 1 BOTTLE, PLASTICGEL10001
81630-002-11Wash-Free Surgical Hand Disinfectant Gel II15 in 1 BOXGEL151
81630-002-12Wash-Free Surgical Hand Disinfectant Gel II5000 mL in 1 PACKAGEGEL50001
81630-002-13Wash-Free Surgical Hand Disinfectant Gel II5 in 1 BOXGEL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81630-002WASH-FREE SURGICAL HAND DISINFECTANT GEL II (ETHANOL) GEL [SHAN DONG LIRCON MEDICAL TECHNOLOGY CO., LTD]1Legacy NDC, 13 package rows20210331_8f17e4a0-831a-4fa2-874a-ad946fa3f0cf.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
81630-00281630-002-01, 81630-002-02, 81630-002-03, 81630-002-04, 81630-002-05, 81630-002-06, 81630-002-07, 81630-002-08, 81630-002-09, 81630-002-10, 81630-002-11, 81630-002-12, 81630-002-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
d2d4f43c-4189-47a8-a2ee-eb513a92db888f17e4a0-831a-4fa2-874a-ad946fa3f0cf2021-03-23WarningsExact identifier
spl id: d2d4f43c-4189-47a8-a2ee-eb513a92db88
spl set id: 8f17e4a0-831a-4fa2-874a-ad946fa3f0cf

Reported adverse events (FAERS/openFDA)#

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