NDC 50563-267 Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand

Benzalkonium Chloride

NDC Product Code 50563-267

NDC CODE: 50563-267

Proprietary Name: Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand 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: Benzalkonium Chloride 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

  • 50563 - Enchante Accessories Inc.
    • 50563-267 - Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand

NDC 50563-267-01

Package Description: 254 mL in 1 BOTTLE

NDC Product Information

Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand with NDC 50563-267 is a a human over the counter drug product labeled by Enchante Accessories Inc.. The generic name of Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Enchante Accessories Inc.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand 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.

  • BENZALKONIUM CHLORIDE .13 g/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.

  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • DISODIUM HEDTA (UNII: KME849MC7A)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Enchante Accessories Inc.
Labeler Code: 50563
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: 09-23-2020 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.

Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand Product Label Images

Body Prescriptions Winter Gardenia Infused With Vitamin E Antibacterial Foaming Hand 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

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

■ For hand washing to decrease bacteria on the skin

Warnings

For external use onlyWhen suing this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if skin irritation develops.

Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Directions

Apply a small amount to hands, lather for seconds, then rinse with warm water.

Other Information

Do not store above 105FMay discolor some fabricsHarmful to wood finishes and plastics

Inactive Ingredients

Water, Cocamidopropyl Betaine, DMDM Hydantoin, Fragrance, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Yellow 5, Red 4, Blue 1

* Please review the disclaimer below.