NDC 78724-104 Wbm Care Wet Wipes

Benzalkonium Chloride

NDC Product Code 78724-104

NDC 78724-104-01

Package Description: 20 POUCH in 1 BAG > 5.8 g in 1 POUCH

NDC 78724-104-02

Package Description: 60 POUCH in 1 BAG > 7.7 g in 1 POUCH

NDC Product Information

Wbm Care Wet Wipes with NDC 78724-104 is a a human over the counter drug product labeled by Jiebao Daily Chemical (xiangxi)co.,ltd. The generic name of Wbm Care Wet Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1038558.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Wbm Care Wet 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.


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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)

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: Jiebao Daily Chemical (xiangxi)co.,ltd
Labeler Code: 78724
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: 12-10-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Wbm Care Wet Wipes Product Label Images

Wbm Care Wet 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

Benzalkonium Chloride ...... 0.13%

Purpose

Antiseptic

Use

Suitable for daily hand and body skin hygiene, indoor cleaning, outdoor supplies, etc.Open the cover, uncover the sticker on the package, extract the wet towel and use it. Please stick the sticker back and cover it tightly after use.

Warning

  • Keep it out of reach of the baby's hands to avoid accidental ingestion. For age 3 and above, Children shall use under the supervision of adult.This product is only suitable for external use and can not be reused.Avoid contact with eyes, mouth and wounds. Please seek for medical help if irritation occurs.Store in a cool and dry place, avoid direct sunlight and high temperature.Keep it sealed to retain moisture.This product cannot be dissolved, please do not thro it into the toilet.

Otc - Keep Out Of Reach Of Children

●If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

  • Wipe hands, fingers, interdigirtal areas and wrists throughly with towelette. Be sure to utilze the entire wipe surface. Allow to dry.

Inactive Ingredients

Aqua, Glycerin, Aloe Yohijyu Matsu Ekisu, Chlorphenesin, Ethylhexyglycerin, Sodium Citrate, Citric Acid, Blook Orange Extract

* Please review the disclaimer below.