NDC 0924-7019 First Aid Only Alcohol Antiseptic Wipe

Alcohol Wipe

NDC Product Code 0924-7019

NDC 0924-7019-00

Package Description: 1 mL in 1 PACKET

NDC 0924-7019-02

Package Description: 50 PACKET in 1 CARTON > 1 mL in 1 PACKET

NDC Product Information

First Aid Only Alcohol Antiseptic Wipe with NDC 0924-7019 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Alcohol Antiseptic Wipe is alcohol wipe. The product's dosage form is swab and is administered via topical form.

Labeler Name: Acme United Corporation

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

First Aid Only Alcohol Antiseptic Wipe Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ISOPROPYL ALCOHOL .7 mL/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Acme United Corporation
Labeler Code: 0924
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-03-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

First Aid Only Alcohol Antiseptic Wipe Product Label Images

First Aid Only Alcohol Antiseptic Wipe Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Active Ingredients Isopropyl Alcohol 70%

Purpose

Antispetic Cleanser

Uses

Uses •For preparation of the skin prior to an injection

Warnings

Warnings •
For external use only.
Flammable, keep away from fire or flame

Do Not Use

Do not use • with electrocautery procedures
•In the eyes. If contact occurs, flush eyes with water

Stop Use

Stop Use if irritation and redness develop. If condition persists consult your health care practicioner.

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DirectionsWipe Injection site vigorously and discard.

Other Safety Information

Other Information Store at room temperature

Inactive Ingredients

Inactive Ingredient purified water

* Please review the disclaimer below.