MedPath

ProCure Alcohol Prep Pads

Approved
Approval ID

87ae4b97-dbe9-4827-905d-4abf42df011e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Twin Med LLC

DUNS: 009579330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Isopropyl Alcohol 70%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55681-051
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol 70%
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (2)

ISOPROPYL ALCOHOLActive
Quantity: .7 mL in 1 1
Code: ND2M416302
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

cartonpouch

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Uses

For preparation of skin prior to injection

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Directions

Wipe injection site vigorously. Discard after use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive Ingredient

Water

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

For external use only

Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/30/2025

When using this product

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/30/2025

Do not use

Do not use with electrocautery procedures

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/30/2025

Stop use if

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active Ingredient

Isopropyl Alcohol 70% v/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

Antiseptic

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ProCure Alcohol Prep Pads - FDA Drug Approval Details