NDC 79288-002 Surface Wipes

Alcohol, Benzalkonium Chloride

NDC Product Code 79288-002

NDC 79288-002-01

Package Description: 50 PATCH in 1 BAG > 9.5 g in 1 PATCH

NDC Product Information

Surface Wipes with NDC 79288-002 is a a human over the counter drug product labeled by Xiamen Yiukin Paper Products Co.,ltd. The generic name of Surface Wipes is alcohol, benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Xiamen Yiukin Paper Products Co.,ltd

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.

Surface 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
  • ALCOHOL 15 mL/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)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)

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: Xiamen Yiukin Paper Products Co.,ltd
Labeler Code: 79288
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: 07-02-2020 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.

Surface Wipes Product Label Images

Surface 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(S)

Alcohol 15%. Purpose: Antisepticbenzalkonium chloride 0.1%. Purpose: Antiseptic

Purpose

Antiseptic, surface wipes

Use

Daily cleaning

Warnings

  • Flammable. Use only in a well-ventilated area. Keep away from flames, such as a pilot light, and any object that sparks, such as an electric motor. For external use only. Avoid contact with eyes or inner mouth. If contact occurs, rinse eyes thoroughly with running water. Do not use on compromised skin. Discontinue use if rash or irratation occurs and consult a doctor. Wash hands thoroughly after handling. Store in a cool dry place. Avoid heat or direct sunlight. Keep seal closed between use to retain moisture. Do not flush. Dispose in a trash receptacle.Keep out of reach of children unless under adult supervision. Do not replace wipes used for medical procedures. These wipes are meant for general cleansing.

Otc - Do Not Use

Do not use on compromised skin.

Otc - When Using

Avoid contact with eyes or inner mouth. If contact occurs, rinse eyes thoroughly with running water.

Otc - Stop Use

Discontinue use if rash or irratation occurs and consult a doctor. Wash hands thoroughly after handling.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children unless under adult supervision.

Directions

Open lid, gently pull back resealable label, remove and use wipes as required.Reseal back after use to avoid evaporation of alcohol.

Other Information

Store in a cool dry place. Avoid heat or direct sunlight. Keep seal closed between use to retain moisture.

Do not flush. Dispose in a trash receptacle.

Inactive Ingredients

Water

* Please review the disclaimer below.