SPL v10
SPL
SPL Set ID 20fc9143-e675-18ae-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Anhydrous Citric Acid Cocamidopropylamine Oxide Laurtrimonium Chloride Coco Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-03
Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Uses
  • For hand washing to decrease bacteria on the skin
  • Recommended for repeated use
Section 51727-6

Inactive Ingredients Water/Agua/Eau, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid

Section 51945-4

Warnings

For external use only

Directions
  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands for 15 seconds
  • Rinse with potable water
When Using

this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Active Ingredient

Benzalkonium Chloride 0.13%

Stop Using and Ask Doctor If

irritation or redness develops, or if condition persists for more than 72 hours.

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 washing to decrease bacteria on the skin
  • Recommended for repeated use
Section 51727-6 (51727-6)

Inactive Ingredients Water/Agua/Eau, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only

Directions
  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands for 15 seconds
  • Rinse with potable water
When Using (When using)

this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.13%

Stop Using and Ask Doctor If (Stop using and ask doctor if)

irritation or redness develops, or if condition persists for more than 72 hours.

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: 2026-02-15T11:56:56.512598 · Updated: 2026-03-14T22:55:45.140912