NDC 80109-000 Rose Health Wipes Antibacterial Hand Wipes, 70 Alcohol

Alcohol

NDC Product Code 80109-000

NDC 80109-000-01

Package Description: 5 PATCH in 1 POUCH > 3.61 mL in 1 PATCH

NDC 80109-000-02

Package Description: 45 PATCH in 1 CANISTER > 3.79 mL in 1 PATCH

NDC 80109-000-03

Package Description: 45 PATCH in 1 CANISTER > 5.46 mL in 1 PATCH

NDC 80109-000-04

Package Description: 80 PATCH in 1 CANISTER > 3.27 mL in 1 PATCH

NDC Product Information

Rose Health Wipes Antibacterial Hand Wipes, 70 Alcohol with NDC 80109-000 is a a human over the counter drug product labeled by Veredrimon Ltd.. The generic name of Rose Health Wipes Antibacterial Hand Wipes, 70 Alcohol is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Veredrimon 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.

Rose Health Wipes Antibacterial Hand Wipes, 70 Alcohol 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 .7 mL/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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: Veredrimon Ltd.
Labeler Code: 80109
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: 09-01-2020 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.

Rose Health Wipes Antibacterial Hand Wipes, 70 Alcohol Product Label Images

Rose Health Wipes Antibacterial Hand Wipes, 70 Alcohol 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

Alcohol Denat 70% V/V

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease, thorough cleaning, with no need for soap and water.

Warnings

For external use only. Flammable. Keep away from heat of fire.

Do Not Use

  • On children less than 2 months of age.on injured or irritated skin.if you are sensitive to any of its ingredients.

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.

Supervise children under 6 years of age when using this product to avoid swallowing.If swallowed, get medical help or contact a Poison Control Center right away.

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, Not in toilet. Always close the resealable label after use to avoid moisture loss.

Other Information

  • Store at room temperature.Avoid freezing and excessive heat above 40C (104F).

Inactive Ingredients:

Aqua, Glycerin, Panthenol, Fragrance, Citric Acid, Limonene.

* Please review the disclaimer below.