NDC 80351-0001 Careme

Alcohol

NDC Product Code 80351-0001

NDC Product Information

Careme with NDC 80351-0001 is a a human over the counter drug product labeled by Gntclean Corp. The generic name of Careme is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Gntclean Corp

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Careme 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.

  • ALCOHOL 30 g/100g

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)
  • CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)

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: Gntclean Corp
Labeler Code: 80351
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: 08-30-2020 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.

Careme Product Label Images

Careme 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

Otc - Active Ingredient

Alcohol

Inactive Ingredient

Water,Glycelin,Sodium Hyaluronate Acid, Aloe Barbadensis Extract,Citrus Limon Fruit Extract, Hydroxyacetophenone,Lauryl Pyridinium Cholride Solution, Dycyl Glucoside

Otc - Purpose

For hand washing to decrease bacteria on the skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Place enough products on hands to cover all surfaces.Close the cap after use

Warnings

For external use onlyWhen using this product■ If any of the following abnormalities occur, the use of the product shall be suspended1) In case of red spots, swelling, itching, or irritation during use2) In case there is an abnormality in the area of application due to direct sunlight3) The scarred part. Do not use in areas such as eczema or dermatitis.Consult a dermatologist as symptoms may worsen.■ Precautions for Storage and Handling1) Close the cap after use.2) Keep it out of reach of the baby.3) Do not store at high or low temperatures or in direct sunlight.4) Do not use except washing hands.■ If there is a problem with this product, it can be exchanged or compensated in accordance with the Fair Trade Commission Notice Consumer Dispute Resolution Standards.

Dosage & Administration

For external use only

* Please review the disclaimer below.