SPL v1
SPL
SPL Set ID 3952873e-5e3f-1bff-e063-6294a90a8a62
Route
TOPICAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.0018 g)
Inactive Ingredients
Water Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-07
Description

BENZALKONIUM CHLORIDE

Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from heat or flame.

Indications and Usage

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration

Place enough product on hands to cover all surfaces.

Description

BENZALKONIUM CHLORIDE

Section 44425-7

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F).

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

Stip use and ack a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thouroughly with water.

Section 50570-1

in children less than 2 months of age.

on open shin wounds.

Section 51727-6

CELLULOSE, WATER, CETYLPYRIDINIUM CHLORIDE, BENZETHONIUM CHLORIDE, PROPYLENE GLYCOL

Section 51945-4

Section 55105-1

Antiseptic, Hand Sanitizer

Section 55106-9

BENZALKONIUM CHLORIDE

Structured Label Content

Indications and Usage (34067-9)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

Place enough product on hands to cover all surfaces.

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from heat or flame.

Section 44425-7 (44425-7)

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F).

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)

Stip use and ack a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thouroughly with water.

Section 50570-1 (50570-1)

in children less than 2 months of age.

on open shin wounds.

Section 51727-6 (51727-6)

CELLULOSE, WATER, CETYLPYRIDINIUM CHLORIDE, BENZETHONIUM CHLORIDE, PROPYLENE GLYCOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic, Hand Sanitizer

Section 55106-9 (55106-9)

BENZALKONIUM CHLORIDE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:29.024808 · Updated: 2026-03-14T23:09:16.713853