NDC 72863-001 Rael Clean Sanitizing Wipes

Benzalkonium Chloride

NDC Product Code 72863-001

NDC 72863-001-01

Package Description: 54 g in 1 PACKAGE

NDC 72863-001-02

Package Description: 108 g in 1 PACKAGE

NDC 72863-001-03

Package Description: 432 g in 1 PACKAGE

NDC Product Information

Rael Clean Sanitizing Wipes with NDC 72863-001 is a a human over the counter drug product labeled by Rael, Inc.. The generic name of Rael Clean Sanitizing Wipes is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Rael, 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.

Rael Clean Sanitizing 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 .1 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.

  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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.
  • 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: Rael, Inc.
Labeler Code: 72863
FDA Application Number: part333E 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: 07-08-2020 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’.

* Please review the disclaimer below.

Rael Clean Sanitizing Wipes Product Label Images

Rael Clean Sanitizing 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

Active Ingredient

Active Ingredients: Benzalkonium Chloride 0.1%

Inactive Ingredient

Inactive Ingredients:Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Tocopheryl acetate, Citric acid

Purpose

Purpose: antiseptic

Keep Out Of Reach Of Children

Keep out of reach of children:


■ If swallowed, get medical help or contact a Posion Control Center right away

Uses

Uses:■ Instant hand antiseptic to decrease bacteria on the skin safe for repeated use.

Warnings

WarningsFor external use onlyStop use and ask a doctor if irrigation or rash develops and continues for more than 72 hours


When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

Directions:■ Wet hands thoroughly with product and allow to dry without wiping■ Discard wipes in trash receptacle after use


■ Do not flush

Other Information

Other information:■ Store in a cool dry place

* Please review the disclaimer below.