FDA.reportPublic FDA data

Obstetrical Antiseptic

Manufacturer
Jiangsu Province JianErKang Medical Dressing Co.,Ltd
Effective date
2010-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:24:12

Label at a glance#

ProductObstetrical Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cat. 40000-200A   NDC 34645-5002-3   Qty.1ea
Obstetrical Antiseptic Towelette
Antiseptic * For Single Use Only
Contains: Benzalkonium Chloride 0.13% w/w
For External Use Only * FOR PROFESSIONAL AND HOSPITAL USE
Caution: Keep out of reach of children
Distributed by:
Cardinal Health
Dublin OH, 43017 USA
Made in China


OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Benzalkonium Chloride, 0.13% w/w

OTC - PURPOSE SECTION

Purpose
First Aid Antiseptic

OTC - WHEN USING SECTION

Use
First aid antiseptic to help prevent skin infection in minor cuts, scrapes, and burns

WARNINGS SECTION

Warnings
For external use only.

OTC - DO NOT USE SECTION

Do not use
in the eyes or apply over large areas of the body
longer than 1 week unless directed by a doctor. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

OTC - STOP USE SECTION

Stop use and consult a doctor
if the condition persists or gets worse

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.

INDICATIONS & USAGE SECTION

Directions
Clean the affected area
Apply a small amount of this product on the area 1 to 3 times daily
May be covered with a sterile bandage when dry

INACTIVE INGREDIENT SECTION

Inactive ingredients
purified water, sodium bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Pouch Label

Pouch LabelPouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
34645-5002-32020-01-31C16284748780-19d75b9d0-883c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-5002-3Obstetrical Antiseptic1.4 mL in 1 POUCHSWAB1.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5002OBSTETRICAL ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,LTD]3Legacy NDC, 1 package rows20100410_e2133042-7387-4eec-863f-55e945e39482.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W73
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y3

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
34645-500234645-5002-3

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
60609692-3bf4-4c40-b5bd-00522b7ae659e2133042-7387-4eec-863f-55e945e394822010-01-01WarningsExact identifier
spl id: 60609692-3bf4-4c40-b5bd-00522b7ae659
spl set id: e2133042-7387-4eec-863f-55e945e39482

Reported adverse events (FAERS/openFDA)#

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