SPL v1
SPL
SPL Set ID 33128e92-5efb-7480-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Sodium Hydroxide Fd&c Red No. 40 D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 5 Water Glycerin Coceth-7 Ppg-1-peg-9 Lauryl Glycol Ether Carbomer Copolymer Type A Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-16
Description

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.1%

Use

To decrease bacteria on the skin that could cause disease.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings
  • For external use only - hands.
  • Keep out of eyes. Avoid contact with broken skin.
  • Stop use and ask a doctor if irritation or redness develops.
  • Do not inhale or ingest. If swallowed, get medical help or contact a poison control center right away,

Direction
  • Rub a dime sized drop into hands.
  • For children under 6 use under adult supervision.
Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance

Structured Label Content

Use

To decrease bacteria on the skin that could cause disease.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings
  • For external use only - hands.
  • Keep out of eyes. Avoid contact with broken skin.
  • Stop use and ask a doctor if irritation or redness develops.
  • Do not inhale or ingest. If swallowed, get medical help or contact a poison control center right away,

Direction
  • Rub a dime sized drop into hands.
  • For children under 6 use under adult supervision.
Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:06.944883 · Updated: 2026-03-14T22:54:20.908479