73288-003 - DailyMed Details

73288-003

SPL v6

SPL

SPL Set ID 94043f4e-fe47-4b6f-8354-30697daaed81

Route

TOPICAL

Published

Effective Date 2019-08-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.4 g)

Inactive Ingredients

Sodium Bicarbonate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-08-29

Description

Active Ingredient: Benzalkonium Chloride 0.4%

Medication Information

Warnings and Precautions

Warnings:

For external use only

Indications and Usage

Uses: For external use. Help prevent infection. Antiseptic cleasing of face, hand, and body withour soap and water.

Dosage and Administration

Directions: Tear open packet, unfold towelette and use to clease desire skin area. Discard towelette appropriately after single use.

Description

Active Ingredient: Benzalkonium Chloride 0.4%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If usual redness, swelling, or other symptoms occur, consult a physician immediately.

Section 51727-6

Inactive Ingredient

Sodium Bicarbonate, Water

Section 51945-4

Section 55105-1

Purpose: First Aide Antiseptic

Section 55106-9

Active Ingredient: Benzalkonium Chloride 0.4%

Section 60561-8

Do not use in the eyes or over large area of the body.

Structured Label Content

Indications and Usage (34067-9)

Uses: For external use. Help prevent infection. Antiseptic cleasing of face, hand, and body withour soap and water.

Dosage and Administration (34068-7)

Directions: Tear open packet, unfold towelette and use to clease desire skin area. Discard towelette appropriately after single use.

Warnings and Precautions (34071-1)

Warnings:

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If usual redness, swelling, or other symptoms occur, consult a physician immediately.

Section 51727-6 (51727-6)

Inactive Ingredient

Sodium Bicarbonate, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: First Aide Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Benzalkonium Chloride 0.4%

Section 60561-8 (60561-8)

Do not use in the eyes or over large area of the body.

Advanced Ingredient Data

[{"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: For external use. Help prevent infection. Antiseptic cleasing of face, hand, and body withour soap and water.", "34068-7": "Directions: Tear open packet, unfold towelette and use to clease desire skin area. Discard towelette appropriately after single use.", "34071-1": "Warnings: For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If usual redness, swelling, or other symptoms occur, consult a physician immediately.", "51727-6": "Inactive Ingredient Sodium Bicarbonate, Water", "55105-1": "Purpose: First Aide Antiseptic", "55106-9": "Active Ingredient: Benzalkonium Chloride 0.4%", "60561-8": "Do not use in the eyes or over large area of the body."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:11.610411 · Updated: 2026-03-14T23:12:21.703136