First Aid Antispetic — v2

First Aid Antispetic

7 Views

Version

v2

Effective date

September 28, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3fe7ba5b-5fc3-c1b7-e063-6394a90a5b15
Set ID
f72851ba-bbdd-5533-e053-6294a90a8216
Application numbers
M005
Product NDCs
49314-0001
Package NDCs
49314-0001-1
Original packager NDCs
—

Names & Manufacturers

Brand names
First Aid Antispetic
Generic names
BENZALKONIUM CHLORIDE
Manufacturer names
Unishield
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
BENZALKONIUM CHLORIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
F5UM2KM3W7
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Benzalkonium chloride 0.13%
Do Not Use (1)

Sequence 1

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
Dosage And Administration (1)

Sequence 1

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 (1)

Sequence 1

Inactive ingredients ethyl alcohol, purified water
Indications And Usage (1)

Sequence 1

Uses first aid to help prevent infection in minor cuts, scrapes and burns
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Package Label - Principal Display Panel image of bottle label
Purpose (1)

Sequence 1

Purpose First aid antiseptic
Questions (1)

Sequence 1

Questions or comments？ 1-800-480-5855
Spl Product Data Elements (1)

Sequence 1

First Aid Antispetic Benzalkonium Chloride WATER ALCOHOL BENZALKONIUM CHLORIDE BENZALKONIUM
Stop Use (1)

Sequence 1

Stop use and ask a doctor if condition persists or gets worse
Warnings (1)

Sequence 1

Warnings For external use only Flammable keep away from fire or flame

OpenFDA raw payload

{'application_number': ['M005'],
 'brand_name': ['First Aid Antispetic'],
 'generic_name': ['BENZALKONIUM CHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Unishield'],
 'package_ndc': ['49314-0001-1'],
 'product_ndc': ['49314-0001'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3fe7ba5b-5fc3-c1b7-e063-6394a90a5b15'],
 'spl_set_id': ['f72851ba-bbdd-5533-e053-6294a90a8216'],
 'substance_name': ['BENZALKONIUM CHLORIDE'],
 'unii': ['F5UM2KM3W7']}