Xpect Antiseptic — v4

Xpect Antiseptic

8 Views

Version

v4

Effective date

September 22, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
d7e7ee0e-159b-4040-ad6b-f40f0c639915
Set ID
d9a31a11-e80f-4ded-ad0a-34f93b01557e
Application numbers
M003
Product NDCs
42961-227
Package NDCs
42961-227-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Xpect Antiseptic
Generic names
BENZALKONIUM CHLORIDE
Manufacturer names
Cintas Corporation
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 ingredients Benzalkonium chloride 0.13%
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have deep or puncture wounds animal bites serious burns
Do Not Use (1)

Sequence 1

Do not use in the eyes or apply over large areas of the body longer than 1 week unless directed by a doctor
Dosage And Administration (1)

Sequence 1

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.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients alcohol, 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.
Other Safety Information (1)

Sequence 1

Other information shake well store at room temperature
Package Label Principal Display Panel (1)

Sequence 1

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
Purpose (1)

Sequence 1

Purpose first aid antiseptic
Questions (1)

Sequence 1

Questions? 1-877-973-2811 M-F 8am-5pm
Spl Product Data Elements (1)

Sequence 1

Xpect Antiseptic benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM ALCOHOL WATER
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 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.

OpenFDA raw payload

{'application_number': ['M003'],
 'brand_name': ['Xpect Antiseptic'],
 'generic_name': ['BENZALKONIUM CHLORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Cintas Corporation'],
 'package_ndc': ['42961-227-01'],
 'product_ndc': ['42961-227'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['d7e7ee0e-159b-4040-ad6b-f40f0c639915'],
 'spl_set_id': ['d9a31a11-e80f-4ded-ad0a-34f93b01557e'],
 'substance_name': ['BENZALKONIUM CHLORIDE'],
 'unii': ['F5UM2KM3W7']}