NDC 70697-802 Cloralen Tm Antibacterial Wipes

Benzalkonium Chloride

NDC Product Code 70697-802

NDC 70697-802-01

Package Description: 24 POUCH in 1 CASE > .375 mg in 1 POUCH

NDC Product Information

Cloralen Tm Antibacterial Wipes with NDC 70697-802 is a a human over the counter drug product labeled by Indelpa, S.a De C.v. The generic name of Cloralen Tm Antibacterial Wipes is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Indelpa, S.a De C.v

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.

Cloralen Tm Antibacterial 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 .125 mg/100mg

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.

  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)

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: Indelpa, S.a De C.v
Labeler Code: 70697
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: 09-01-2020 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.

Cloralen Tm Antibacterial Wipes Product Label Images

Cloralen Tm Antibacterial 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

Otc - Purpose

Antibacterial

Otc - Active Ingredient

BENZALKONIUM, CHLORIDE 0.125%

Indications & Usage

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Otc - Do Not Use

If you are allergic to any of the ingredients

Otc - When Using

Do not get into eyes.If contact occurs, rinse throughly with water

Otc - Stop Use

If irritation or rash develops and continues for more than 72 hours

Otc - Ask Doctor

If irritation or rash develops and continues for more than 72 hours

Otc - Keep Out Of Reach Of Children

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

Instructions For Use

- wet hands throughly with product and allow to dry.-discard wipe in trash receptacle after use. Do not flush- chuldren under 6 years af age should be supervised whe using this product

Inactive Ingredient

Water, propylene glycol USP, polysorbate 20, sodium cocoamphoacetate, fragrance, methylchloroisothiazolinone / methylisothiazolinone, aloe vera extract, tetrasodium EDTA, citric acid, acetate D alpha- tocopherol

Dosage & Administration

Topical admistration

* Please review the disclaimer below.