bed2d4e2-8225-2458-e053-2a95a90aca57

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

Active Ingredient

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)

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

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (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)

Use (USE)

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

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

Advanced Ingredient Data

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE": "First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns", "34071-1": "For external use only", "50565-1": "keep out of reach of children", "50566-9": "irritation and redness develop if condition persists for more than 72 hours, consult a physician", "50569-3": "deep or puncture wounds animal bites serious burns", "50570-1": "as a first aid antiseptic for more than 1 week in the eyes over large areas of the body", "51727-6": "purified water", "55105-1": "Antiseptic", "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)"}

Additional Information

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