First Aid Antispetic
49314-0001-1 Unishield First Aid Antiseptic spray
Approved
Approval ID
f72851ba-bbdd-5533-e053-6294a90a8216
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 28, 2025
Manufacturers
FDA
Unishield
DUNS: 790677053
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 Code49314-0001
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 28, 2025
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 mg in 1 mL
Code: F5UM2KM3W7
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/28/2025
Package Label - Principal Display Panel
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/28/2025
Uses
first aid to help prevent infection in minor cuts, scrapes and burns
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 9/28/2025
Active ingredient
Benzalkonium chloride 0.13%
WARNINGS SECTION
LOINC: 34071-1Updated: 9/28/2025
Warnings
For external use only
Flammable keep away from fire or flame
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 9/28/2025
Purpose
First aid antiseptic
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 9/28/2025
Do not use
- near eyes or mucous membranes
- on deep or puncture wounds , animal bites, or serious burns
- over large areas of the body
- more than one week unless directed by a doctor
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 9/28/2025
Stop use and ask a doctor
if condition persists or gets worse
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 9/28/2025
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: 9/28/2025
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 of years of age
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 9/28/2025
Inactive ingredients
ethyl alcohol, purified water
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 9/28/2025
Questions or comments？
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