NDC 55239-554 Pharma-c-wipes Toallitas De Alcohol Isopropilico 70

Isopropyl Alcohol

NDC Product Code 55239-554

NDC CODE: 55239-554

Proprietary Name: Pharma-c-wipes Toallitas De Alcohol Isopropilico 70 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Isopropyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 55239 - Kleen Test Products Corporation
    • 55239-554 - Pharma-c-wipes Toallitas De Alcohol Isopropilico 70

NDC 55239-554-00

Package Description: 40 PATCH in 1 CANISTER > 4.5 mL in 1 PATCH

NDC Product Information

Pharma-c-wipes Toallitas De Alcohol Isopropilico 70 with NDC 55239-554 is a a human over the counter drug product labeled by Kleen Test Products Corporation. The generic name of Pharma-c-wipes Toallitas De Alcohol Isopropilico 70 is isopropyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Kleen Test Products Corporation

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.

Pharma-c-wipes Toallitas De Alcohol Isopropilico 70 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/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.

  • 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: Kleen Test Products Corporation
Labeler Code: 55239
FDA Application Number: part333E 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: 04-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Pharma-c-wipes Toallitas De Alcohol Isopropilico 70 Product Label Images

Pharma-c-wipes Toallitas De Alcohol Isopropilico 70 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

Ingrediente Inactivo

Alcohol Isopropilico

Agua purificada

Proposito

Antiseptico para primeros auxilios

Usos

  • Primeros auxlios para prevenir riesgo the infeccion:cortadas menoresrasponesquemaduras

Advertencias

Solo para uso externoInflamable mantengase alejado del fuego, llamas, calor, chispas, o equipo electrico

Consulte A Un Medico Antes De Usar Si Tiene

  • Heridas profundas o punzantesmordidas de animalesquemaduras graves

Al Utilizar Este Producto

  • No utilizar en los ojosNo aplique en areas grandesNo utilizar por mas de una semana salvo por orden medica

Suspenda Su Uso Y Consulte A Su Medico

Si los sintomas persisten o empeoran.

Mantenganse Fuera Del Alcance De Los Niños

Si se ingiere, busque ayuda medica o contacte a un centro de intoxicationes inmediatamente.

Direcciones

  • Limpie el area afectada aplique el producto enel area del cuerpo afectada de 1 a 3 veces al diase puede cubrir con venda esterilizadadejar secar el area antes de vendar

Informacion Adicional

  • No usar internamentemantenga el recipimient cerrado y a temperatura ambientealejelo de la cara al abrir

Preguntas O Comentarios?

1-844-308-8600

* Please review the disclaimer below.