Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID e2133042-7387-4eec-863f-55e945e39482
Route
TOPICAL
Published
Effective Date 2009-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.0013 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2006-01-01
Description

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

Medication Information

Warnings and Precautions
Warnings

For external use only.

Indications and Usage
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

Description

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

Section 50565-1
Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9
Stop use and consult a doctor

if the condition persists or gets worse

Section 50567-7
Use

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

Section 50570-1
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.

Section 51727-6

Inactive ingredients

purified water, sodium bicarbonate

Section 51945-4
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





Section 55105-1
Purpose

First Aid Antiseptic

Section 55106-9
Active ingredient

Benzalkonium Chloride, 0.13% w/w

Structured Label Content

Indications and Usage (34067-9)
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

Warnings and Precautions (34071-1)
Warnings

For external use only.

Section 50565-1 (50565-1)
Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
Stop use and consult a doctor

if the condition persists or gets worse

Section 50567-7 (50567-7)
Use

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

Section 50570-1 (50570-1)
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.

Section 51727-6 (51727-6)

Inactive ingredients

purified water, sodium bicarbonate

Section 51945-4 (51945-4)
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





Section 55105-1 (55105-1)
Purpose

First Aid Antiseptic

Section 55106-9 (55106-9)
Active ingredient

Benzalkonium Chloride, 0.13% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:02.321553 · Updated: 2026-03-14T22:52:21.082332