SPL v2
SPL
SPL Set ID 205eb8f9-55fd-266e-e063-6294a90a4b3e
Route
TOPICAL
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Sodium Laureth Sulfate Sodium Chloride Glycerin Ditetracycline Tetrasodium Edetate Water Cocamidopropyl Betaine Anhydrous Citric Acid Methylchloroisothiazolinone Methylisothiazolinone Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-08
Description

Benzalkonium Chloride - 0.13%

Medication Information

Warnings and Precautions

Warning For external use only

Indications and Usage

Uses for handwashing or decrease bacteria to the skin

Dosage and Administration

Direction

  • Wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse
Description

Benzalkonium Chloride - 0.13%

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation or redness develops

Section 50567-7

When using the product

  • Do not get into eyes. If contact occurs rinse eye thoroughly with water
Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Red #33

Section 51945-4

Section 55105-1

Purpose - Antibacterial

Section 55106-9

Benzalkonium Chloride - 0.13%

Structured Label Content

Indications and Usage (34067-9)

Uses for handwashing or decrease bacteria to the skin

Dosage and Administration (34068-7)

Direction

  • Wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse
Warnings and Precautions (34071-1)

Warning For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or redness develops

Section 50567-7 (50567-7)

When using the product

  • Do not get into eyes. If contact occurs rinse eye thoroughly with water
Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1, Red #33

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose - Antibacterial

Section 55106-9 (55106-9)

Benzalkonium Chloride - 0.13%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:12.011490 · Updated: 2026-03-14T23:06:40.095610