SPL v1
SPL
SPL Set ID 64914c6a-aea3-3c30-e053-2a91aa0a88b0
Route
TOPICAL
Published
Effective Date 2017-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Hydroxyethyl Ethylcellulose Edetic Acid Phenoxyethanol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-01-30
Description

Active Ingredient Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions

Warnings

  • for external use only
  • if irritation occurs discontinue use
  • keep out of eyes
  • avoid contact with broken skin
  • do not inhale or ingest
  • stop use and ask if doctor if skin irritation develops
  • keep out of reach of children
  • if swallowed, get medical help or contact a poison control center right away.
Indications and Usage

To decrease bacteria on hands

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/aqua, hydroxyethylcellulose, phenoxyethanol, fragrance/parfum, disodium edta

Section 51945-4

Section 55105-1

Antibacterial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.1%

Structured Label Content

Indications and Usage (34067-9)

To decrease bacteria on hands

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
  • if irritation occurs discontinue use
  • keep out of eyes
  • avoid contact with broken skin
  • do not inhale or ingest
  • stop use and ask if doctor if skin irritation develops
  • keep out of reach of children
  • 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, hydroxyethylcellulose, phenoxyethanol, fragrance/parfum, disodium edta

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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: 2026-02-15T11:56:30.499511 · Updated: 2026-03-14T22:55:01.972489