MedPath

Redicare Alcohol Prep Pads

Approved
Approval ID

3cb7fba1-1d2d-f4da-e063-6394a90a4b21

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 19, 2025

Manufacturers
FDA

Redicare LLC

DUNS: 800149346

Products 1

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

Medium Alcohol Prep Pads

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71105-006
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Medium Alcohol Prep Pads
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 19, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/19/2025

Alcohol Swab- Medium Prep Pad Box of 100

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/19/2025

Use

For preparation of the skin prior to injection; to decrease germs in minor cuts and scrapes.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/19/2025

Inactive ingredients:

Water

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/19/2025

Other information:

Store at room temperature

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/19/2025

Active Ingredients

Isopropyl alcohol 70% v/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/19/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/19/2025

Warnings:

For external use only. Flammable; keep away from fire and flame.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Caution:

Do not apply to irritated skin.

Do not use

in the eyes, or on mucous membranes. In case of deep or puncture wounds, consult a doctor.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/19/2025

Directions:

Wipe injection site vigorously.

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