NDC 34645-0004 Jianerkang Wipes

Alcohol

NDC Product Code 34645-0004

NDC 34645-0004-1

Package Description: 50 POUCH in 1 BAG > 10.466 mL in 1 POUCH

NDC Product Information

Jianerkang Wipes with NDC 34645-0004 is a a human over the counter drug product labeled by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. The generic name of Jianerkang Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Jiangsu Province Jianerkang Medical Dressing 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.

Jianerkang 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.

  • ALCOHOL .75 mL/mL

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)

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: Jiangsu Province Jianerkang Medical Dressing Co., Ltd
Labeler Code: 34645
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: 04-30-2020 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.

Jianerkang Wipes Product Label Images

Jianerkang 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

Alcohol 75% by volume

Purpose

Antiseptic

Use

  • AntisepticFor handwashing to decrease bacteria on the skin.For sanitizing hands after ill persons, or prior to contacting with a person under medical care treatment.Topical application to skin to help prevent cross-contamination.

Warnings

  • Flammable. Keep away from fire, flame or sources of ignition. i.e. electrocautery procedures.For external use only.

Otc - Do Not Use

  • Do not use in or contact with eyes.

Otc - Stop Use

  • Discontinue use if irritation and redness develop. If condition persists more than 72 hours, consult a doctor.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children unless under adult supervision.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply wipe thoroughly onto hands and allow to dry. No rinsing required.Discard after single use. Dispose if used wpes in trash receptacle. Don not flush.If hands are visibly soiled or contaminated, use first wipe to clean hands, then discard wipe, sanitize with a second wipe.When not in use, keep lid closed to prevent evaporation.

Inactive Ingredients

Water

Otc - Questions

Questions? Call 400-828-2133

* Please review the disclaimer below.