Wash-Free Surgical Hand Disinfectant Gel

Manufacturer
Shan Dong Lircon Medical Technology Co., Ltd
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:16:58

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 attached81630-001-0281630-001-02 81630-001-0281630-001-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81630-001-022024-08-07C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-042024-08-07C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-062024-08-07C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-082024-08-07C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-112024-08-07C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-132024-08-07C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-022024-07-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-042024-07-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-062024-07-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-082024-07-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-112024-07-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-132024-07-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-022024-01-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-042024-01-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-062024-01-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-082024-01-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-112024-01-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing
81630-001-132024-01-30C16284748780-11030e365-6625-111a-e063-dadaa90a10e2SPL file for drug listing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81630-001-01Wash-Free Surgical Hand Disinfectant GelII60 mL in 1 BOTTLE, PLASTICGEL604
81630-001-02Wash-Free Surgical Hand Disinfectant GelII10 in 1 BOXGEL104
81630-001-03Wash-Free Surgical Hand Disinfectant GelII248 mL in 1 BOTTLE, PLASTICGEL2484
81630-001-04Wash-Free Surgical Hand Disinfectant GelII40 in 1 BOXGEL404
81630-001-05Wash-Free Surgical Hand Disinfectant GelII500 mL in 1 BOTTLE, PLASTICGEL5004
81630-001-06Wash-Free Surgical Hand Disinfectant GelII25 in 1 BOXGEL254
81630-001-07Wash-Free Surgical Hand Disinfectant GelII1000 mL in 1 BOTTLE, PLASTICGEL10004
81630-001-08Wash-Free Surgical Hand Disinfectant GelII16 in 1 BOXGEL164
81630-001-09Wash-Free Surgical Hand Disinfectant GelII10 in 1 BOXGEL104
81630-001-10Wash-Free Surgical Hand Disinfectant GelII1000 mL in 1 BOTTLE, PLASTICGEL10004
81630-001-11Wash-Free Surgical Hand Disinfectant GelII15 in 1 BOXGEL154
81630-001-12Wash-Free Surgical Hand Disinfectant GelII5000 mL in 1 PACKAGEGEL50004
81630-001-13Wash-Free Surgical Hand Disinfectant GelII5 in 1 BOXGEL54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81630-001WASH-FREE SURGICAL HAND DISINFECTANT GEL II (ETHANOL) GEL [SHAN DONG LIRCON MEDICAL TECHNOLOGY CO., LTD]4Legacy NDC, 13 package rows20240809_7eab998d-b6ab-482f-a6ac-e314f8f2a0a5.zip

Products#

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NDC Codes#

Ingredients#

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

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

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
557712a5-5eaf-4164-822c-4743c58adf637eab998d-b6ab-482f-a6ac-e314f8f2a0a52024-08-08WarningsExact identifier
spl id: 557712a5-5eaf-4164-822c-4743c58adf63
spl set id: 7eab998d-b6ab-482f-a6ac-e314f8f2a0a5

Reported adverse events (FAERS/openFDA)#

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