NDC 63517-210 Antibacterial Bathing

Benzalkonium Chloride

NDC Product Code 63517-210

NDC 63517-210-22

Package Description: 8 POUCH in 1 PACKET > 1 PATCH in 1 POUCH > 13.775 mL in 1 PATCH

NDC Product Information

Antibacterial Bathing with NDC 63517-210 is a a human over the counter drug product labeled by Cardinal Health, Inc.. The generic name of Antibacterial Bathing is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Cardinal Health, Inc.

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It 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.

Antibacterial Bathing 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 1.3 mg/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.

  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MYRISTAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: E4821CQM1I)
  • LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ALLANTOIN (UNII: 344S277G0Z)

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: Cardinal Health, Inc.
Labeler Code: 63517
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: 05-15-2019 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: 12-31-2020 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.

Antibacterial Bathing Product Label Images

Antibacterial Bathing 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

  • To decrease bacteria on skin

Warnings

For external use onlyDo not heat sealed package in microwave

Ask A Doctor Before You Use If You Have:

  • Deep puncture woundsAnimal bitesSerious burns

Keep Out Of Reach Of Children.

  • In case of accidental ingestion seek medical help or contact a Poison Control Center immediately.Gloves diminish sensitivity to heatClosely monitor heat level with infants, unresponsive or skin sensitive individuals

Do Not Use

  • In the eyeLonger than 1 week unless directed by a physicianOver raw surfaces or blistered areas

Directions

  • Cloths can be used at room temperature or heated in a wipes warmer for extra comfort. Warming Instructions:single warming session at temperatures not to exceed 52˚C (125˚F) andfor a maximum of 200 hours.Discard wipes that have been exposed to warming temperatures exceeding 52˚C (125˚F) orstored longer than 200 hours in the warmer. Bathing Instructions:Remove one cloth at a time to clean each area in the following order: 1. Neck & facial area; 2. Front torso; 3. Right arm; 4. Left arm; 5. Right leg; 6. Left leg; 7. Back torso; 8. Buttocks & perineal areaAllow skin to dryDispose of cloth in waste receptacleDo not flush cloths in toilet

Inactive Ingredients

Aqua, Phenoxyethanol, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Myristamidopropyl PG-Dimonium Chloride Phosphate, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citric Acid, Disodium EDTA, Allantoin.

* Please review the disclaimer below.

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