SPL v2
SPL
SPL Set ID ee8a2af2-0572-19b1-e053-2995a90a23ae
Route
TOPICAL
Published
Effective Date 2022-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 g)
Inactive Ingredients
Dihydroxyethyl Cocamine Oxide Water Cocamidopropyl Pg-dimonium Chloride Phosphate Cetrimonium Chloride Fragrance 13576 Citric Acid Monohydrate Laurtrimonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-31
Description

Benzalkonium chloride 0.1%

Purpose

antiseptic

Medication Information

Purpose

antiseptic

Description

Benzalkonium chloride 0.1%

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

Section 51945-4

Warnings

For external use only

when using this product avoid contact with eyes. in case of eye contact, flush eyes with water

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

keep out of reach of children. if swallowed, get medical help or contact a poison control center right away

Directions

pump a small amount of foam into palm of hand

rub thoroughly over all surfaces of both hands

rub hands together briskly until dry

Questions?

1-800-537-8990

Active Ingredients

Benzalkonium chloride 0.1%

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Centimonium Chloride, Lautrimonium Chloride, Dihydroxyethyl cocamide oxide, citric acid, fragrance

Structured Label Content

Uses

For hand sanitizing to decrease bacteria on the skin

Recommended for repeated use

Section 51945-4 (51945-4)

Purpose

antiseptic

Warnings

For external use only

when using this product avoid contact with eyes. in case of eye contact, flush eyes with water

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

keep out of reach of children. if swallowed, get medical help or contact a poison control center right away

Directions

pump a small amount of foam into palm of hand

rub thoroughly over all surfaces of both hands

rub hands together briskly until dry

Questions?

1-800-537-8990

Active Ingredients

Benzalkonium chloride 0.1%

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Centimonium Chloride, Lautrimonium Chloride, Dihydroxyethyl cocamide oxide, citric acid, fragrance

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:32.790085 · Updated: 2026-03-14T23:02:10.811423