NDC 63148-200 Hdx Antibacterial Hand

Benzalkonium Chloride

NDC Product Code 63148-200

NDC Code: 63148-200

Proprietary Name: Hdx Antibacterial Hand Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 63148 - Apollo Health And Beauty Care Inc.
    • 63148-200 - Hdx Antibacterial Hand

NDC 63148-200-10

Package Description: 3785 mL in 1 PACKAGE

NDC Product Information

Hdx Antibacterial Hand with NDC 63148-200 is a a human over the counter drug product labeled by Apollo Health And Beauty Care Inc.. The generic name of Hdx Antibacterial Hand is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Apollo Health And Beauty Care Inc.

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 Additional informationCallout TooltipWhat 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.


Hdx Antibacterial Hand Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1.3 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • SODIUM SULFATE (UNII: 0YPR65R21J)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Apollo Health And Beauty Care Inc.
Labeler Code: 63148
FDA Application Number: part333E Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-21-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Hdx Antibacterial Hand Product Label Images

Hdx Antibacterial 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

Uses

Helps eliminate bacteria on hands.

Warnings

For external use only.

When Using This Product

Avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop Use 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

  • Use to refill a hand soap pump bottlefrom pump bottle, apply onto wet handslather and rinse thoroughly

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

* Please review the disclaimer below.

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