NDC 81725-614 Xtraguard Antibacterial Hand Wipes

Benzalkonium Chloride

NDC Product Code 81725-614

NDC 81725-614-01

Package Description: 30 POUCH in 1 BAG > .13 g in 1 POUCH

NDC 81725-614-10

Package Description: 2 BAG in 1 CARTON > 30 POUCH in 1 BAG > .13 g in 1 POUCH

NDC 81725-614-15

Package Description: 3 BAG in 1 CARTON > 30 POUCH in 1 BAG > .13 g in 1 POUCH

NDC 81725-614-20

Package Description: 2 BAG in 1 CARTON > 30 POUCH in 1 BAG > .13 g in 1 POUCH

NDC 81725-614-25

Package Description: 3 BAG in 1 CARTON > 30 POUCH in 1 BAG > .13 g in 1 POUCH

NDC Product Information

Xtraguard Antibacterial Hand Wipes with NDC 81725-614 is a a human over the counter drug product labeled by Munchkin Inc.. The generic name of Xtraguard Antibacterial Hand Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Munchkin Inc.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Xtraguard Antibacterial Hand Wipes 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/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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

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: Munchkin Inc.
Labeler Code: 81725
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: 05-26-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Xtraguard Antibacterial Hand Wipes Product Label Images

Xtraguard Antibacterial Hand Wipes 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

Dosage & Administration

30 Wipes | 1 wipe: 8 in. x 4 in. (20.3 cm x 10.2 cm)

Otc - Active Ingredient

Benzalkonium Chloride 0.13% - Antimicrobial

Otc - Purpose

Antimicrobial

Indications & Usage

  • UsesTo sanitize hands and decrease bacteria on skinRecommended for repeated use

Warnings

WarningsFor external use only.When using this product avoid contact with eyes. If contact occurs, wash using water and discontinue use.

Otc - Ask Doctor

Stop use and ask a doctor if irritation or redness develops or if condition persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Instructions For Use

  • DirectionsWet hands thoroughly with wipe.Allow to dry without wiping.Discard wipe in trash after use. Do not flush in toilet.

Storage And Handling

  • Other informationKeep away from direct sunlight. Store at room temperature.

Inactive Ingredient

Inactive ingredientsWater, Glycerin, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Tocopheryl Acetate

* Please review the disclaimer below.