SPL v1
SPL
SPL Set ID 3d7d6e73-2a50-cac9-e063-6294a90a7891
Route
CUTANEOUS
Published
Effective Date 2025-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.05 g) Alcohol (75 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-08-29
Description

Purpose: Antiseptic

Medication Information

Warnings and Precautions

Warnings:

Flammability: Flammable. Keep from heat/sparks/flames.

Eye Contact: Avoid contact. Flush with water if contact.

Skin Irritation: Stop use if irritation/redness. Consult doctor.

Open Wounds: Do not use on open wounds unless doctor directs.

Swallowing: If swallowed, seek medical help/poison control.

Storage: Store cool/ventilated. Away from heat, kids/animals.

Repeated Use: Repeated use may dry skin.

Indications and Usage

Use: For skin only. Do not ingest.

Dosage and Administration

Directions of Use:

Open the lid and slowly peel back label.2. Pull out wipes as needed.3. Reseal label to retain moisture.

Description

Purpose: Antiseptic

Section 50565-1

Keep out of reach of Children: Supervise kids <6.

Section 51727-6

Inactive ingredients: RO pure water

Section 51945-4

Label

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active ingredients: Ethyl alcohol 75%; Benzalkonium Chloride 0.05%

Structured Label Content

Indications and Usage (34067-9)

Use: For skin only. Do not ingest.

Dosage and Administration (34068-7)

Directions of Use:

Open the lid and slowly peel back label.2. Pull out wipes as needed.3. Reseal label to retain moisture.

Warnings and Precautions (34071-1)

Warnings:

Flammability: Flammable. Keep from heat/sparks/flames.

Eye Contact: Avoid contact. Flush with water if contact.

Skin Irritation: Stop use if irritation/redness. Consult doctor.

Open Wounds: Do not use on open wounds unless doctor directs.

Swallowing: If swallowed, seek medical help/poison control.

Storage: Store cool/ventilated. Away from heat, kids/animals.

Repeated Use: Repeated use may dry skin.

Section 50565-1 (50565-1)

Keep out of reach of Children: Supervise kids <6.

Section 51727-6 (51727-6)

Inactive ingredients: RO pure water

Section 51945-4 (51945-4)

Label

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active ingredients: Ethyl alcohol 75%; Benzalkonium Chloride 0.05%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:53.108696 · Updated: 2026-03-14T23:09:55.704959