MedPath

ECOLAB Antiseptic

ECOLAB Antiseptic Spray

Approved
Approval ID

4c982e7b-2489-151f-e054-00144ff88e88

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

ECOLAB Food Safety and Specialties, Inc.

DUNS: 618996086

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzalkonium Chloride 0.13%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71338-122
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride 0.13%
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (3)

BENZALKONIUM CHLORIDEActive
Quantity: 1.3 g in 1 L
Code: F5UM2KM3W7
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/9/2021

ECOLAB®

Antiseptic Spray

Reorder

17

Treats minor cuts, scrapes and abrasions. Helps Prevent infection.

2 fl oz (59 mL)

Benzalkonium chloride 0.13%

Antiseptic

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/7/2017

Uses

First aid to help prevent infections & for temporary pain relief of minor cuts, scrapes & burns.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/7/2017

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/7/2017

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 4/7/2017

Warnings

For external use only.

Flammable, keepaway from fire or flame.

Do not use

  • near eyes or mucus membranes
  • on deep or puncture wounds, animal bites, or serious burns
  • over large areas of the body
  • for more than one week unless directed by a doctor

Stop use and ask a doctor ifcondition persisits or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/7/2017

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/7/2017

Directions

  • clean affected area & spray 1 to 3 times daily
  • may be covered with a sterile bandage
  • not to be used on children under 12 years of age

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/7/2017

Inactive ingredientsethyl alcohol, purified water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/9/2021

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