61333-207 - DailyMed Details

61333-207

SPL v1

SPL

SPL Set ID 1cb146c4-3c3c-4efa-98a8-2284a3cee87f

Route

TOPICAL

Published

Effective Date 2022-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.133 g)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2022-03-07

Description

benzalkonium chloride 0.133%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

benzalkonium chloride 0.133%

Uses

Antiseptic cleaning of face, hands and body to decrease bacteria on skin without soap and water.

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water

Section 51945-4

Warnings

For external use only.

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours

Directions

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping

Active Ingredient

benzalkonium chloride 0.133%

Structured Label Content

Uses

Antiseptic cleaning of face, hands and body to decrease bacteria on skin without soap and water.

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 51727-6 (51727-6)

Water

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only.

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours

Directions

Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping

Active Ingredient (Active ingredient)

benzalkonium chloride 0.133%

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.133", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Antiseptic cleaning of face, hands and body to decrease bacteria on skin without soap and water.", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Water", "Purpose": "Antiseptic", "Warnings": "For external use only. Do not use in the eyes. If this happens, rinse thoroughly with water Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours", "Directions": "Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping", "Active ingredient": "benzalkonium chloride 0.133%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:07.937558 · Updated: 2026-03-14T23:00:28.895348