SPL v1
SPL
SPL Set ID ec872c41-1cf0-40df-a455-9e4a138b316b
Route
TOPICAL
Published
Effective Date 2023-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Ethylhexylglycerin Phenoxyethanol Water Propylene Glycol Didecyldimonium Chloride Fragrance Lemon Orc2001060 Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-08-22
Description

Benzalkonium Chloride (0.13%)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride (0.13%)

Use

For hand-washing to decrease bacteria on skin

Section 50565-1

Keep out of reach of childrenexcept under adult supervision.If swallowed, get medical help or contact a Poison Control Center right away.

Warnings
  • Flammable. Keep away from heat and flame.
  • For External use only.
  • Do not usein eyes. In case of contact, rinse thoroughly with water.
  • Stop use & ask doctorif rash/redness or irritation appears/develops and persist for more than 72 hours.
Directions
  • Slowly peel back label and use one wipe. Reseal, keep closed to prevent evaporation.
  • Thoroughly wipe hands, allow to dry out rinsing. 
  • Discard after single use.
Product Label

Active Ingredient

Benzalkonium Chloride (0.13%)

Inactive Ingredients

Water, phenoxyethanol, ethylhexyl glycerin, didecyldimonium chloride, propylene glycol, glycerin, fragrance.

Structured Label Content

Use

For hand-washing to decrease bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of childrenexcept under adult supervision.If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Warnings
  • Flammable. Keep away from heat and flame.
  • For External use only.
  • Do not usein eyes. In case of contact, rinse thoroughly with water.
  • Stop use & ask doctorif rash/redness or irritation appears/develops and persist for more than 72 hours.
Directions
  • Slowly peel back label and use one wipe. Reseal, keep closed to prevent evaporation.
  • Thoroughly wipe hands, allow to dry out rinsing. 
  • Discard after single use.
Product Label (Product label)

Active Ingredient

Benzalkonium Chloride (0.13%)

Inactive Ingredients (Inactive ingredients)

Water, phenoxyethanol, ethylhexyl glycerin, didecyldimonium chloride, propylene glycol, glycerin, fragrance.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:07.034030 · Updated: 2026-03-14T23:01:17.657881