NDC 78985-004 Electronic Devices Disinfecting Wipes

Isopropyl Alcohol

NDC Product Code 78985-004

NDC 78985-004-09

Package Description: 30 SWAB in 1 POUCH

NDC 78985-004-17

Package Description: 90 SWAB in 1 CANISTER

NDC 78985-004-21

Package Description: 100 SWAB in 1 CANISTER

NDC 78985-004-22

Package Description: 10 SWAB in 1 POUCH

NDC 78985-004-23

Package Description: 20 SWAB in 1 POUCH

NDC Product Information

Electronic Devices Disinfecting Wipes with NDC 78985-004 is a a human over the counter drug product labeled by Generic Specialties Inc.. The generic name of Electronic Devices Disinfecting Wipes is isopropyl alcohol. The product's dosage form is swab and is administered via topical form.

Labeler Name: Generic Specialties Inc.

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.

Electronic Devices Disinfecting 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 70 mL/1001

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: Generic Specialties Inc.
Labeler Code: 78985
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: 09-30-2020 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.

Electronic Devices Disinfecting 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

Other

This is an Electronic Devices Disinfecting Wipes manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.The hand sanitizing & moisturizing wipes are manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:Alcohol (Isopropyl alcohol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Purified water
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product

Active Ingredient(S)

Isopropyl Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Safe and easy way to clean electronics- Clean TVs, Phones & other Electronics.

Use

Electronic Devices Disinfecting Wipes to clean and help reduce bacteria that potentially cause disease.

Warnings

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

Do Not Use

-

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - 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 at 1-800-222-1222

Directions

  • Open the resealable label and pull wipe.Wipe the area. Wipe thoroughly all parts of area you want to clean, repeat as needed. No need to rinse with water. Dispose of wipe in trash after use. Do not flush. Always close the resealble label after use to avoid moisture loss.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Purified water

Recent Major Changes

Electronic Devices Disinfecting Wipes to clean and help reduce bacteria that potentially can cause disease.

* Please review the disclaimer below.