Tr-1331 Ndc 55550-210-70

SPL v5

SPL

SPL Set ID 7978430f-9408-3516-e053-2a91aa0aa62d

Route

TOPICAL

Published

Effective Date 2018-10-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2018-06-01

Description

Benzalkonium Chloride, 0.13%

Purpose

First Aid Antiseptic

Medication Information

Purpose

First Aid Antiseptic

Description

Benzalkonium Chloride, 0.13%

Use

Antiseptic cleansing of face, hands and body without the use of soap and water. Air dries in seconds.

Label

Section 50565-1

If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings

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

Directions

Tear open packet, unfold, and use as a washcloth.

Questions?

Call 1-888-771-7824

Stop Use If

irritation, redness or other symptoms develop. Cosult a doctor if the condition persists or worsens.

Active Ingredient

Benzalkonium Chloride, 0.13%

Other Information

Store at room temperature 59° - 86°F (15° - 30°C)

Inactive Ingredient

water

Structured Label Content

Use

Antiseptic cleansing of face, hands and body without the use of soap and water. Air dries in seconds.

Label

Section 50565-1 (50565-1)

If swallowed, seek medical help or contact a Poison Control Center immediately.

Purpose

First Aid Antiseptic

Warnings

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

Directions

Tear open packet, unfold, and use as a washcloth.

Questions?

Call 1-888-771-7824

Stop Use If (Stop use if)

irritation, redness or other symptoms develop. Cosult a doctor if the condition persists or worsens.

Active Ingredient (Active ingredient)

Benzalkonium Chloride, 0.13%

Other Information (Other information)

Store at room temperature 59° - 86°F (15° - 30°C)

Inactive Ingredient (Inactive ingredient)

water

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic cleansing of face, hands and body without the use of soap and water. Air dries in seconds.", "50565-1": "If swallowed, seek medical help or contact a Poison Control Center immediately.", "Purpose": "First Aid Antiseptic", "Warnings": "Do not use in the eyes or apply over large areas of the body.", "Directions": "Tear open packet, unfold, and use as a washcloth.", "Questions?": "Call 1-888-771-7824", "Stop use if": "irritation, redness or other symptoms develop. Cosult a doctor if the condition persists or worsens.", "Active ingredient": "Benzalkonium Chloride, 0.13%", "Other information": "Store at room temperature 59° - 86°F (15° - 30°C)", "Inactive ingredient": "water"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:22.949644 · Updated: 2026-03-14T23:00:47.249871