NDC 81509-0001 Booyoung Mask

Polypropylene

NDC Product Code 81509-0001

NDC 81509-0001-1

Package Description: 3 g in 1 PACKAGE

NDC Product Information

Booyoung Mask with NDC 81509-0001 is a a human over the counter drug product labeled by Boo Young Precision Co.,ltd. The generic name of Booyoung Mask is polypropylene. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Boo Young Precision Co.,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.

Booyoung Mask 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.

  • POLYPROPYLENE (30000 MW) 99 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.

  • 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: Boo Young Precision Co.,ltd
Labeler Code: 81509
Marketing Category: UNAPPROVED DRUG OTHER - 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: 02-11-2021 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 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.

Booyoung Mask Product Label Images

Booyoung Mask 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

Polypropylene

Inactive Ingredient

Water

Otc - Purpose

Protects neck and skin from dry air for deep sleep

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Place the mask on your face to cover your nose and chin

Warnings

1. For external use only.1) Do not use over the wound and irritated skin with eczema or infections2) Store in a cool and dry place, away from direct sun light

Dosage & Administration

For external use only

* Please review the disclaimer below.