e8e669b7-902e-4ca6-9e0f-5d8e6f28041b

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

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.13%

Medication Information

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.

Purpose

Antiseptic

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

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

Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredient

5% v/v alcohol,Purified Water

Structured Label Content

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.

Purpose

Antiseptic

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

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)

Active Ingredients

Benzalkonium Chloride 0.13%

Inactive Ingredient

5% v/v alcohol,Purified Water

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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.", "50565-1": "Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.", "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"}

Additional Information

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