NDC 81353-026 Guardex Sanitizing Hand

Guardex Sanitizing Hand with NDC 81353-026 is a a human over the counter drug product labeled by Nile Hudson Llc. The generic name of Guardex Sanitizing Hand is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Nile Hudson Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Guardex Sanitizing 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 .95 g/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.

• MALTODEXTRIN (UNII: 7CVR7L4A2D)
• MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
• WATER (UNII: 059QF0KO0R)
• ETHYLHEXYL PALMITATE (UNII: 2865993309)
• SHEA BUTTER (UNII: K49155WL9Y)
• ALOE VERA LEAF (UNII: ZY81Z83H0X)
• LAURETH-30 (UNII: W9D845551A)
• PHENOXYETHANOL (UNII: HIE492ZZ3T)
• C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
• AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
• PANTHENOL (UNII: WV9CM0O67Z)
• CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
• ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Nile Hudson Llc
Labeler Code: 81353
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: 12-26-2020 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’.

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