SPL v2
SPL
SPL Set ID ee8be683-f935-b32b-e053-2995a90aa51f
Route
TOPICAL
Published
Effective Date 2022-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Benzalkonium Chloride 0.1% w/w

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride 0.1% w/w

Use
  • 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, if condition persists for more than 72 hours consult a doctor.

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

Warnings Section

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

Active Ingredient

Benzalkonium Chloride 0.1% w/w

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Citric Acid, Fragrance

Structured Label Content

Use
  • 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, if condition persists for more than 72 hours consult a doctor.

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

Warnings Section

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

Active Ingredient

Benzalkonium Chloride 0.1% w/w

Inactive Ingredients

Water, Cocomidopropyl PG-Dimonium Chloride Phosphate, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Citric Acid, Fragrance

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:32.791082 · Updated: 2026-03-14T23:02:10.811423