NDC 77617-012 Magicshine Antibacterial Foaming Hand

Benzalkonium Chloride

NDC Product Code 77617-012

NDC 77617-012-02

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 3.80564 kg in 1 BOTTLE, PLASTIC (77617-012-01)

NDC Product Information

Magicshine Antibacterial Foaming Hand with NDC 77617-012 is a a human over the counter drug product labeled by Maintex. The generic name of Magicshine Antibacterial Foaming Hand is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Maintex

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 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.

Magicshine 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 kg/100kg

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)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
  • BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

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: Maintex
Labeler Code: 77617
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: 09-18-2018 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.

Magicshine Antibacterial Foaming Hand Product Label Images

Magicshine 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

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When Using This Product

- Avoid contact with the eyes.- If contact occurs, rinse eyes thoroughly with water. Do not ingest.- Stop use and contact a doctor if irritation and redness develop  and if conditions persist.

Keep Out Of Reach Of Children.

Keep out of reach of children. If swallowed, get medical helpor contact a Poison Control Center immediately.

Directions

-Apply to wet hands, work into a lather and rinse thoroughly.-Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Caprylyl Glucoside, Glycerine, Tetrasodium EDTA, Benzisothiazol, Methylisothiozol, Fragrance, Citric Acid, Aloe Vera, Yellow #5, Red #40.

Magicshine Antibacterial Foaming Hand Soap

Magicshine Antibacterial Foaming Hand Soap

* Please review the disclaimer below.