NDC 78553-3910 Sanitizing Alcohol Wipes

Alcohol

NDC Product Code 78553-3910

NDC 78553-3910-1

Package Description: 80 CLOTH in 1 CANISTER

NDC Product Information

Sanitizing Alcohol Wipes with NDC 78553-3910 is a a human over the counter drug product labeled by Unitrex Ltd.. The generic name of Sanitizing Alcohol Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Unitrex Ltd.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It 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.

Sanitizing Alcohol Wipes 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 1 mL/1

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.
  • 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: Unitrex Ltd.
Labeler Code: 78553
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: 06-01-2020 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: 12-31-2021 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.

Sanitizing Alcohol Wipes Product Label Images

Sanitizing Alcohol Wipes 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 Ingredient

Isopropyl Alcohol 75% v/v

Purpose

Antimicrobial

Use

To help reduce bacteria, fungi, and viruses on the skin

Warnings

For external use only.Flammable. Keep away from heat or flame.

Do Not Use

Do not use in the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop Use

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

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

  • Wet hands thoroughly with product and allow to dry.Discard wipe in trash receptacle after use. Do not flush.Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Distilled Water

Storage

Storage Conditions: Store in a cool and dry environment. Avoid high temperature environment and keep away from fire sources.

Other

  • SparoomSANITIZING ALCOHOL WIPESIsopropyl Alcohol 75%Shelf life:Sealed/Unopened: 2 YearsOpened: 90 DaysOther Information: May discolor certain fabrics or surfaces.Distributed by Unitrex Ltd. / SpaRoom
  • 5060 Taylor Rd, Cleveland OH 44128
  • © 2020 Unitrex
  • Questions? www.sparoom.com
  • Made in China
  • 80 PCS Container

* Please review the disclaimer below.