SPL v1
SPL
SPL Set ID bed2d4e2-8225-2458-e053-2a95a90aca57
Route
TOPICAL
Published
Effective Date 2021-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-31
Description

Benzalkonium Chloride

Medication Information

Warnings and Precautions

For external use only

Description

Benzalkonium Chloride

Use

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

Section 50565-1

keep out of reach of children

Section 50566-9

irritation and redness develop

if condition persists for more than 72 hours, consult a physician

Section 50569-3

deep or puncture wounds

animal bites

serious burns

Section 50570-1

as a first aid antiseptic for more than 1 week

in the eyes

over large areas of the body

Section 51727-6

purified water

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium Chloride

Directions

clean affected area

apply 1 to 3 times daily

may be covered with a sterile bandage

if bandaged let dry first

Other Information

stor at room temperaturel15°-30° C (59°-86° F)

Structured Label Content

Use (USE)

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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

keep out of reach of children

Section 50566-9 (50566-9)

irritation and redness develop

if condition persists for more than 72 hours, consult a physician

Section 50569-3 (50569-3)

deep or puncture wounds

animal bites

serious burns

Section 50570-1 (50570-1)

as a first aid antiseptic for more than 1 week

in the eyes

over large areas of the body

Section 51727-6 (51727-6)

purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride

Directions (DIRECTIONS)

clean affected area

apply 1 to 3 times daily

may be covered with a sterile bandage

if bandaged let dry first

Other Information (OTHER INFORMATION)

stor at room temperaturel15°-30° C (59°-86° F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:29.180351 · Updated: 2026-03-14T22:59:29.411693