SPL v1
SPL
SPL Set ID dea9f2ac-61ee-4541-bb04-c8d289facb82
Route
TOPICAL
Published
Effective Date 2015-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.06 mg)
Inactive Ingredients
Water Glycerin Coceth-7 Carboxylic Acid Ppg-1 Trideceth-6 Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Sodium Hydroxide Peg-40 Castor Oil Fd&c Red No. 40 D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-29
Description

Active Ingredient Benzalkonium Chloride 0.1% Purpose Antibacterial

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

May Contain

Red 40 (Cl 16035)

Red 33 (Cl 17200)

Blue 1 (Cl42045)

Yellow 5 (Cl 19140)

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% Purpose Antibacterial

Section 50565-1

keep out of reach of children

Section 51727-6

Inactive Ingredients

water (aqua/eau), glycerin, coceth-7, ppg-1-peg-9 lauryl glycol etyher, carbomer, sodium hydroxide, peg-40 hydrogenated castor oil, fragrance/parfum.

Section 51945-4

Section 55105-1

Use

To decrease bacteria on the skin that could cause disease.

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Structured Label Content

Indications and Usage (34067-9)

May Contain

Red 40 (Cl 16035)

Red 33 (Cl 17200)

Blue 1 (Cl42045)

Yellow 5 (Cl 19140)

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 (aqua/eau), glycerin, coceth-7, ppg-1-peg-9 lauryl glycol etyher, carbomer, sodium hydroxide, peg-40 hydrogenated castor oil, fragrance/parfum.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Use

To decrease bacteria on the skin that could cause disease.

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:55.524253 · Updated: 2026-03-14T22:53:59.046955