SPL v1
SPL
SPL Set ID 4f4541df-76d4-351b-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-11
Description

Active Ingredient Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

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.
Indications and Usage

Use

To decrease bacteria on the skin that could cause disease

Dosage and Administration

Directions

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

Active Ingredient Benzalkonium Chloride 0.1%

Section 50565-1

keep out of reach of children

Section 51727-6

Inactive ingredients

water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance, may contain: red 40, red 33, blue 1, yellow 5.

Section 51945-4

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.1%

Structured Label Content

Indications and Usage (34067-9)

Use

To decrease bacteria on the skin that could cause disease

Dosage and Administration (34068-7)

Directions

  • Rub a dime sized drop into hands.
  • For children under 6 use under adult supervision.
Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

water, glycerin, coceth-7, PPG-1-PEG-9 lauryl glycol ether, carbomer, sodium hydroxide, PEG-40 hydrogenated castor oil, fragrance, may contain: red 40, red 33, blue 1, yellow 5.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:19.366662 · Updated: 2026-03-14T22:54:43.254033