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help it Antiseptic

43473-078 Antiseptic Spray

Approved
Approval ID

0b22f423-eb11-445f-a484-9326c1fe3ad5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Nantong Health & Beyond Hygienic Products Inc.

DUNS: 421280161

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 Code43473-078
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
BENZALKONIUM CHLORIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 mL
Code: F5UM2KM3W7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/27/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/27/2025

Uses

To help prevent infection in minor cuts, scrapes, and burns

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/27/2025

Active ingredient

BENZALKONIUM CHLORIDE 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/27/2025

Purpose

Fist Aid Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/27/2025

Warnings

For external use only.

Flammable: keep away from fire or flames

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/27/2025

Do not use

  • near eyes or mucous 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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/27/2025

Stop use and ask a doctor if condition persists or get worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/27/2025

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: 5/27/2025

Directions:

  • Clean affected area and spray 1-3 times daily
  • Cover with a sterile bandage
  • Not to be used on children under 12 years of age

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/27/2025

Inactive ingredients

ethyl alcohol, purified water

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help it Antiseptic - FDA Drug Approval Details