MedPath

Xpect Antiseptic

Xpect Antiseptic Spray

Approved
Approval ID

d9a31a11-e80f-4ded-ad0a-34f93b01557e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 22, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

Products 1

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

benzalkonium chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-227
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
benzalkonium chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (3)

BENZALKONIUM CHLORIDEActive
Quantity: 0.13 mg in 1 mL
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: 9/22/2025

Principal Display Panel

ANTISEPTIC SPRAY

Helps Prevent Infection

Convenient pump spray allows no-touch

application. Use as a first aid treatment

for minor cuts and scrapes. Soothes and

cools. Water-Soluble.

2 fl. oz. (59.1 mL)

Xpect® First aid

bottle_label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/19/2023

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/22/2025

Active ingredients

Benzalkonium chloride 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/19/2023

Purpose

first aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 4/19/2023

Warnings

For external use only

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists or gets worse

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: 4/19/2023

Directions

  • clean the affected area
  • spray a small amount 1 to 3 times daily
  • may be covered with a sterile bandage.
  • if bandaged, let dry first.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/19/2023

Other information

  • shake well
  • store at room temperature

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/19/2023

Inactive ingredients

alcohol, water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/19/2023

Questions?

1-877-973-2811 M-F 8am-5pm

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