NDC 74680-200 Wipex

Anti-microbial Wipe

NDC Product Code 74680-200

NDC 74680-200-63

Package Description: 400 CLOTH in 1 CONTAINER

NDC 74680-200-86

Package Description: 800 CLOTH in 1 PACKAGE

NDC Product Information

Wipex with NDC 74680-200 is a a human over the counter drug product labeled by Unico International Trading Corp. The generic name of Wipex is anti-microbial wipe. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Unico International Trading Corp

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.

Wipex 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 .001 1/1
  • BENZALKONIUM CHLORIDE .001 1/1

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • WATER (UNII: 059QF0KO0R)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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.
  • 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: Unico International Trading Corp
Labeler Code: 74680
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: 05-27-2020 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.

Wipex Product Label Images

Wipex 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 0.1%

Keep Out Of The Reach Of Children.

Keep out of the reach of children, except with adult supervision.

Warnings

For external use only. Do not use in the eyes. Keep out of eyes. In case of eye contact, rinse with water. If irritation develops, discontinue use. Consult doctor if irritation continues for more than 72 hours. If swallowed, seek medical attention or call a poison control center.

Inactice Ingredients

Aqua, Decyl Glucoside, Glycerin, Sodium Hydroxymethylglycinate, Citric Acid, PEG-12 Dimethicone Copolyol, Tetrasodium EDTA, Potassium Sorbate, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Charmomilla Recutita (Matricaria),Flower Extract, Allantoin, Panthenol, Tocopheryl Acetate

Purpose

Anti-bacterial

To Dispense

Locate tear-notch on top of refill pouch. Tear straight across to open. Pull first wipe from center of roll through the pouch center opening. Thread wipe through dispenser nozzle. Use only upward pull dispensers.

To Use

Sanitize hands or other affected area. Discard in trash after use.

* Please review the disclaimer below.