43473-078 Antiseptic Spray

43473-078 Antiseptic Spray
SPL v1
SPL
SPL Set ID 0b22f423-eb11-445f-a484-9326c1fe3ad5
Route
TOPICAL
Published
Effective Date 2025-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-27
Description

Active ingredient BENZALKONIUM CHLORIDE 0.13%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable: keep away from fire or flames

Indications and Usage

Uses

To help prevent infection in minor cuts, scrapes, and burns

Dosage and Administration

Directions:

  • Clean affected area and spray 1-3 times daily
  • Cover with a sterile bandage
  • Not to be used on children under 12 years of age
Description

Active ingredient BENZALKONIUM CHLORIDE 0.13%

Section 50565-1

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

Stop use and ask a doctor if condition persists or get worse

Section 50570-1

Do not use

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • for more than one week unless directed by a doctor
Section 51727-6

Inactive ingredients

ethyl alcohol, purified water

Section 51945-4

Section 55105-1

Purpose

Fist Aid Antiseptic

Section 55106-9

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

Structured Label Content

Indications and Usage (34067-9)

Uses

To help prevent infection in minor cuts, scrapes, and burns

Dosage and Administration (34068-7)

Directions:

  • Clean affected area and spray 1-3 times daily
  • Cover with a sterile bandage
  • Not to be used on children under 12 years of age
Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable: keep away from fire or flames

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 50569-3 (50569-3)

Stop use and ask a doctor if condition persists or get worse

Section 50570-1 (50570-1)

Do not use

  • near eyes or mucous membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • for more than one week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

ethyl alcohol, purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Fist Aid Antiseptic

Section 55106-9 (55106-9)

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:10.571309 · Updated: 2026-03-14T23:08:48.977444