SPL v2
SPL
SPL Set ID eb1d4d76-c2df-475a-98bb-541a5ea75769
Route
TOPICAL
Published
Effective Date 2018-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (.13 g)
Inactive Ingredients
Water Coco Glucoside Laurtrimonium Chloride Cocamidopropylamine Oxide Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-01
Description

Active ingredient Benzalkonium Chloride 0.13%

Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes

thoroughly with water.

Stop use and ask a doctor if irritation or redness develop, or if condition persists for more

than 72 hours.

Indications and Usage

Uses   •For hand washing to decrease bacteria on the skin

         •Recommended for repeated use

Dosage and Administration

Directions   •Pump a small amount of foam into palm of hand.

•Rub thoroughly over all surfaces of both hands for 15 seconds.   •Rinse with potable water.

Description

Active ingredient Benzalkonium Chloride 0.13%

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

Inactive ingredients  Water (Aqua), coco-glucoside, laurtrimonium chloride,

coamidopropylamine oxide, citric acid

Section 51945-4

Section 53413-1

Questions or comments? 781-803-7800   •[email protected]

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%

Structured Label Content

Indications and Usage (34067-9)

Uses   •For hand washing to decrease bacteria on the skin

         •Recommended for repeated use

Dosage and Administration (34068-7)

Directions   •Pump a small amount of foam into palm of hand.

•Rub thoroughly over all surfaces of both hands for 15 seconds.   •Rinse with potable water.

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes

thoroughly with water.

Stop use and ask a doctor if irritation or redness develop, or if condition persists for more

than 72 hours.

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)

Inactive ingredients  Water (Aqua), coco-glucoside, laurtrimonium chloride,

coamidopropylamine oxide, citric acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 781-803-7800   •[email protected]

Section 55105-1 (55105-1)

Purpose

Antimicrobial

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: 2026-02-15T11:56:32.297212 · Updated: 2026-03-14T22:55:04.352870