ProCure Alcohol Prep Pads — v1

ProCure Alcohol Prep Pads

3 Views

Version

v1

Effective date

September 30, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
be93381a-696c-4e37-b2d3-4dc8349e554a
Set ID
87ae4b97-dbe9-4827-905d-4abf42df011e
Application numbers
505G(a)(3)
Product NDCs
55681-051
Package NDCs
55681-051-01, 55681-051-02
Original packager NDCs
—

Names & Manufacturers

Brand names
ProCure Alcohol Prep Pads
Generic names
ISOPROPYL ALCOHOL 70%
Manufacturer names
Twin Med LLC
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ISOPROPYL ALCOHOL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
ND2M416302
UPC
0816516012495

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient Isopropyl Alcohol 70% v/v
Do Not Use (1)

Sequence 1

Do not use Do not use with electrocautery procedures
Dosage And Administration (1)

Sequence 1

Directions Wipe injection site vigorously. Discard after use.
Inactive Ingredient (1)

Sequence 1

Inactive Ingredient Water
Indications And Usage (1)

Sequence 1

Uses For preparation of skin prior to injection
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

carton pouch
Purpose (1)

Sequence 1

Purpose Antiseptic
Spl Product Data Elements (1)

Sequence 1

ProCure Alcohol Prep Pads Isopropyl Alcohol 70% ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER
Stop Use (1)

Sequence 1

Stop use if Stop use if irritation or redness develop. If condition persists for more than 72 hours, consult a doctor
Warnings (1)

Sequence 1

Warnings For external use only Flammable. Keep away from fire or flame.
When Using (1)

Sequence 1

When using this product When using this product , avoid contact with the eyes. In case of contact, flush thoroughly with water.

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['ProCure Alcohol Prep Pads'],
 'generic_name': ['ISOPROPYL ALCOHOL 70%'],
 'is_original_packager': [True],
 'manufacturer_name': ['Twin Med LLC'],
 'package_ndc': ['55681-051-01', '55681-051-02'],
 'product_ndc': ['55681-051'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['be93381a-696c-4e37-b2d3-4dc8349e554a'],
 'spl_set_id': ['87ae4b97-dbe9-4827-905d-4abf42df011e'],
 'substance_name': ['ISOPROPYL ALCOHOL'],
 'unii': ['ND2M416302'],
 'upc': ['0816516012495']}