SPL v2
SPL
SPL Set ID e8e669b7-902e-4ca6-9e0f-5d8e6f28041b
Route
TOPICAL
Published
Effective Date 2014-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-11
Description

Benzalkonium Chloride  0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride  0.13%

Use

Cleasing of face,hands and body without soap and water.Air dryies in seconds.

Non-sterile solution

Applicator is sterile if package is intact.

Section 50565-1

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Section 51945-4

Warnings

For external use only

Flammable,keep away for fire or flame

Do not use:

* In large quantities

* over large areas of the body

* in eyes

* over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Directions

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.

Children under 2 years of age ; Consult a doctor

Active Ingredients

Benzalkonium Chloride  0.13%

Inactive Ingredient

5% v/v alcohol,Purified Water

Structured Label Content

Use

Cleasing of face,hands and body without soap and water.Air dryies in seconds.

Non-sterile solution

Applicator is sterile if package is intact.

Section 50565-1 (50565-1)

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only

Flammable,keep away for fire or flame

Do not use:

* In large quantities

* over large areas of the body

* in eyes

* over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Directions

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.

Children under 2 years of age ; Consult a doctor

Active Ingredients

Benzalkonium Chloride  0.13%

Inactive Ingredient

5% v/v alcohol,Purified Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:07.430642 · Updated: 2026-03-14T22:54:20.908479