SPL v1
SPL
SPL Set ID 1509ef50-c1d6-4161-8674-e644a8811684
Route
TOPICAL
Published
Effective Date 2020-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Sodium Bicarbonate Cocamidopropyl Propylene Glycol-dimonium Chloride Phosphate Hydroxyethyl Cellulose, Unspecified Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-18
Description

Benzalkonium Chloride 0.13% 

Purpose

Antimicrobial and First Aid Antiseptic

Medication Information

Purpose

Antimicrobial and First Aid Antiseptic

Description

Benzalkonium Chloride 0.13% 

Uses

For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations and skin infections.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with eyes. Incase of eye contact, flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Warnings

For external use only.

Directions
  • Pump onto hands as needed. Rub briskly until dry.
  • Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.
Active Ingredient

Benzalkonium Chloride 0.13% 

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Water, Sodium Bicarbonate, Colalipid C, Hydroxyethyl Cellulose, Green Tea Leaf Extract.

Package Label Principal Display Panel

Structured Label Content

Uses

For hand sanitizing to decrease bacteria on the skin. As a wound antiseptic to help prevent bacterial contamination in cuts, burns, scrapes, lacerations and skin infections.

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 50567-7 (50567-7)

When using this product avoid contact with eyes. Incase of eye contact, flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Purpose

Antimicrobial and First Aid Antiseptic

Warnings

For external use only.

Directions
  • Pump onto hands as needed. Rub briskly until dry.
  • Apply to wounds 3 times per day after cleaning. Allow to dry. May be bandaged once dry.
Active Ingredient

Benzalkonium Chloride 0.13% 

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Water, Sodium Bicarbonate, Colalipid C, Hydroxyethyl Cellulose, Green Tea Leaf Extract.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:51.500845 · Updated: 2026-03-14T22:58:38.353182