MedPath

Non-proprietary name

Alcohol Prep Pad

Approved
Approval ID

edaff0ca-f305-71a4-e053-2a95a90a5dca

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 2, 2025

Manufacturers
FDA

Guangzhou Four E's Scientific Co., Ltd.

DUNS: 560465588

Products 1

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

Alcohol Prep Pad

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83118-010
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Alcohol Prep Pad
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 2, 2025
FDA Product Classification

INGREDIENTS (2)

ISOPROPYL ALCOHOLActive
Quantity: 0.8 g in 1 1
Code: ND2M416302
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/1/2022

Packet

Packet

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/1/2022

Directions

- Open Packet -Remove Pad

- Apply topically as needed to cleanse intended area

- Discard after single use

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/1/2022

Active Ingredient

Isopropyl Alcohol, 70% v/v

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/1/2022

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 12/1/2022

Warnings

For external use only

- Flammable, keep away from fire or flame

- Do not use with electrocautery procedures

- Do not use in the eyes

- Do not apply to irritated skin

- Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician

Keep out of reach of children

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/1/2022

Inactive Ingrdient

Purified Water

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 12/1/2022

Other Information

- Store at room temperature 59-86°F (15-30°C)

- Content STERILE in unopened, undamaged package

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/1/2022

Keep out of reach of children

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/1/2022

Purpose

Antiseptic

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Non-proprietary name - FDA Drug Approval Details