SPL v2
SPL
SPL Set ID a84ec7b9-121c-498a-e053-2995a90a900b
Route
TOPICAL
Published
Effective Date 2020-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01
Description

Benzalkonium Chloride 0.13%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage



• For hand washing to decrease bacteria on the skin

• Recommended for repeated use

Dosage and Administration

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

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 50566-9

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7

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

Section 51727-6

Inactive ingredients Water, laurtrimonium chloride, alkyl polyglucoside, uv indicator cocamidopropylamine oxide, alkyl polyglycoside, citric acid

Section 51945-4

Section 55105-1

Antimicrobial

Section 55106-9

Benzalkonium Chloride 0.13%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)



• For hand washing to decrease bacteria on the skin

• Recommended for repeated use

Dosage and Administration (34068-7)

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

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 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Section 50567-7 (50567-7)

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

Section 51727-6 (51727-6)

Inactive ingredients Water, laurtrimonium chloride, alkyl polyglucoside, uv indicator cocamidopropylamine oxide, alkyl polyglycoside, citric acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antimicrobial

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:58:23.631467 · Updated: 2026-03-14T22:57:55.937889