NDC 74548-014 Pasion Alcohol Wet Wipes

Alcohol

NDC Product Code 74548-014

NDC 74548-014-01

Package Description: 20 PATCH in 1 BOX > 5 mL in 1 PATCH

NDC Product Information

Pasion Alcohol Wet Wipes with NDC 74548-014 is a a human over the counter drug product labeled by Ming Fai Enterprise International Co., Ltd. The generic name of Pasion Alcohol Wet Wipes is alcohol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Ming Fai Enterprise International Co., Ltd

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Pasion Alcohol Wet 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.

  • ALCOHOL .72 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)
  • TEA TREE OIL (UNII: VIF565UC2G)

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: Ming Fai Enterprise International Co., Ltd
Labeler Code: 74548
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: 05-01-2020 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.

Pasion Alcohol Wet Wipes Product Label Images

Pasion Alcohol Wet 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 Ingredient

Ethyl Alcohol 72% (v/v)

Purpose

Antibacterial

Uses

• to help reduce bacteria on the skin.

Warnings

• For external use only. • Do not dispose of wipes in flush toilets.

Other

Flammable • Keep away from fire or flame.

When Using This Product

• avoid contact with eyes. • If contact occurs, rinse thoroughly with water.

Stop Using And Ask A Doctor If

• irritation or redness develops and lasts.

Keep Out Of Reach Of Children

• In case of accidental ingestion, get medical help or contact a poison control center immediately.

Directions

• Apply to hands or skin.  No rinsing required.  Discard after use.

Other Information

• Store below 110°F (43°C).• May discolor certain fabrics or surfaces

Inactive Ingredients

Aqua (Water), Glycerin, Polyquaternium-37, Melaleuca Alternifolia Leaf Oil

* Please review the disclaimer below.