SPL v2
SPL
SPL Set ID ce3f2d21-f7ba-46d2-87c2-f7257de151eb
Route
TOPICAL
Published
Effective Date 2014-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.0026 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-22
Description

Active Ingredient: Benzalkonium Chloride (0.13%)

Medication Information

Warnings and Precautions

Warnings:

For external use only

Avoid contact with eyes. If contact occurs, flush eyes with water.

Indications and Usage

Use: Antiseptic cleasing of face, hands, and body without soap and water. Air dries in seconds.

Dosage and Administration

Directions:

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard toweletted appropriately after single use.

Description

Active Ingredient: Benzalkonium Chloride (0.13%)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

Section 50569-3

Stop use if irritation, redness, or other syptoms develop.

Consult a doctor if condition persists or gets worse.

Section 51727-6

Inactive Ingredient

Purified water

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Section 55106-9

Active Ingredient: Benzalkonium Chloride (0.13%)

Structured Label Content

Indications and Usage (34067-9)

Use: Antiseptic cleasing of face, hands, and body without soap and water. Air dries in seconds.

Dosage and Administration (34068-7)

Directions:

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard toweletted appropriately after single use.

Warnings and Precautions (34071-1)

Warnings:

For external use only

Avoid contact with eyes. If contact occurs, flush eyes with water.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

Section 50569-3 (50569-3)

Stop use if irritation, redness, or other syptoms develop.

Consult a doctor if condition persists or gets worse.

Section 51727-6 (51727-6)

Inactive Ingredient

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Section 55106-9 (55106-9)

Active Ingredient: Benzalkonium Chloride (0.13%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.290022 · Updated: 2026-03-14T22:53:45.950699