SPL v2
SPL
SPL Set ID 470fca9f-a819-2290-e063-6294a90abad8
Route
TOPICAL
Published
Effective Date 2025-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Sodium Bicarbonate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-28
Description

Benzalkonium Chloride, 0.13% w/w

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Directions

Clean the affected area.

Dosage and Administration

Apply topically as needed to cleanse intendend area；

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Description

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Not made with natural rubber latex.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if condition persists or gets worse.

Section 50570-1

Do not use in the eyes or over large areas of the body.

Ask a doctor before use if you have deep or puncture wounds or serious burns.

Section 51727-6

Sodium bicarbonate, purified water

Section 51945-4

Section 55105-1

Antiseptic.

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Section 55106-9

Benzalkonium Chloride, 0.13% w/w

Structured Label Content

Indications and Usage (34067-9)

Directions

Clean the affected area.

Dosage and Administration (34068-7)

Apply topically as needed to cleanse intendend area；

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Warnings and Precautions (34071-1)

For external use only.

Description (34089-3)

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Not made with natural rubber latex.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition persists or gets worse.

Section 50570-1 (50570-1)

Do not use in the eyes or over large areas of the body.

Ask a doctor before use if you have deep or puncture wounds or serious burns.

Section 51727-6 (51727-6)

Sodium bicarbonate, purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic.

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Section 55106-9 (55106-9)

Benzalkonium Chloride, 0.13% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.868696 · Updated: 2026-03-14T23:12:02.945870