NDC 96386-002 Sanitary Wet Tissue

Sanitary Wet Tissue

NDC Product Code 96386-002

NDC 96386-002-01

Package Description: 50 CLOTH in 1 PACKET

NDC Product Information

Sanitary Wet Tissue with NDC 96386-002 is a a human over the counter drug product labeled by Weihai Hai Na Bai Chuan Pharmaceutical Group. The generic name of Sanitary Wet Tissue is sanitary wet tissue. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Weihai Hai Na Bai Chuan Pharmaceutical Group

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.

Sanitary Wet Tissue 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.

  • ISOPROPYL ALCOHOL 150 mL/501

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Weihai Hai Na Bai Chuan Pharmaceutical Group
Labeler Code: 96386
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: 08-31-2020 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.

Sanitary Wet Tissue Product Label Images

Sanitary Wet Tissue 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)

Isopropanol

Purpose

Suitable for hands,skin and surface of common objects

Use

This product is suitable for cleaning and sterilizing hands,skin and surface of common objects.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

This prodcut is for extermal use only.avoid contact with eyes.please stop using it if you feel uncomfortable

Otc - Stop Use

This product is forbidden for those who are allergic to alcohol,please stop using it and seek medical advice in time if there's any allergic reaction

Otc - Keep Out Of Reach Of Children

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

Usage

Open the lid,remove the sticker on the outer package,and extract the wet tissue,please stick the sticker back to its original place after use to prevent it from drying out

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Glycerin, propylene glycol, purified water

* Please review the disclaimer below.