NDC 81257-101 Miracle Saniquick Sanitizing Wipes

Isopropyl Alcohol

NDC Product Code 81257-101

NDC 81257-101-01

Package Description: 60 PACKAGE in 1 CANISTER > 4 mL in 1 PACKAGE

NDC 81257-101-02

Package Description: 80 PACKAGE in 1 CANISTER > 4 mL in 1 PACKAGE

NDC 81257-101-03

Package Description: 100 PACKAGE in 1 CANISTER > 4 mL in 1 PACKAGE

NDC Product Information

Miracle Saniquick Sanitizing Wipes with NDC 81257-101 is a a human over the counter drug product labeled by Miracle Industries. The generic name of Miracle Saniquick Sanitizing Wipes is isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Miracle Industries

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.

Miracle Saniquick Sanitizing 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 75 mL/100mL

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

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: Miracle Industries
Labeler Code: 81257
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: 12-16-2020 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.

Miracle Saniquick Sanitizing Wipes Product Label Images

Miracle Saniquick Sanitizing 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 Ingredients

Isopropyl Alcohol 75% v/v

Purpose

Antiseptic.

Uses

Sanitizing Hand Wipes to help decrease bacteria on the skin.Recommended for single use.

Warning :

Do not freeze. Foe external use only. Store at room TemperatureDo not use in ears, eyes or mouth.• Avoid contact with the eyes. In case of contact, flush eyes with water.• Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.Flammable : keep away from fire or flame, heat, spark, electrical

Directions For Use :

Pull one sheet from canister clean hands or affected area & discard,Close lid after if used to keep wipes fresh.

Inactive Ingredients :

Glycerine, Aloe Vera extract, vitamin E, fragrance

Questions?

Call +1 9708895372 (Mon-Fri 9am to 5pm) www.miracleindustries.co.in

* Please review the disclaimer below.