SPL v3
SPL
SPL Set ID 72bb2762-41c9-4213-9a76-4c3e9b358383
Route
TOPICAL
Published
Effective Date 2021-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Cetrimonium Chloride Laurtrimonium Chloride Dihydroxyethyl Cocamine Oxide Glycereth-17 Cocoate Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-23
Description

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial 

Medication Information

Purpose

Antimicrobial 

Description

Benzalkonium Chloride 0.1%

Uses
  • for hand sanitizing to decrease the bacteria on the skin
  • recommended for repeated use

Warnings

For external use only. 

When using this productavoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor ifirritation or redness develops, or if condition persists for more than 72 hours.

Directions
  • pump a small amount of foam into palm of hand 
  • rub thoroughly over all surfaces of both hands 
  • rub hands together briskly until dry 
Product Label

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water, cetrimonium chloride, Laurtrimonium chloride, Dihydroxyethyl Cocamine oxide, citric acid, glycereth-17 cocoate

Keep Out of Reach of Children

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

Structured Label Content

Uses
  • for hand sanitizing to decrease the bacteria on the skin
  • recommended for repeated use

Purpose

Antimicrobial 

Warnings

For external use only. 

When using this productavoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor ifirritation or redness develops, or if condition persists for more than 72 hours.

Directions
  • pump a small amount of foam into palm of hand 
  • rub thoroughly over all surfaces of both hands 
  • rub hands together briskly until dry 
Product Label (Product label)

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Water, cetrimonium chloride, Laurtrimonium chloride, Dihydroxyethyl Cocamine oxide, citric acid, glycereth-17 cocoate

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:07.269174 · Updated: 2026-03-14T23:12:59.392851