NDC 79650-100 All-purpose Sanitizing Wipes

Sanitizing Wipes

NDC Product Code 79650-100

NDC 79650-100-75

Package Description: 200 mL in 1 BAG

NDC Product Information

All-purpose Sanitizing Wipes with NDC 79650-100 is a a human over the counter drug product labeled by Zhangzhou Zhongnan Nursing Products Co., Ltd.. The generic name of All-purpose Sanitizing Wipes is sanitizing wipes. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Zhangzhou Zhongnan Nursing Products Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

All-purpose Sanitizing 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/100mL

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)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • 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: Zhangzhou Zhongnan Nursing Products Co., Ltd.
Labeler Code: 79650
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: 09-29-2020 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.

All-purpose Sanitizing Wipes Product Label Images

All-purpose Sanitizing 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

Otc - Active Ingredient

Ethanol Alcohol 75%

Otc - Purpose

​Antiseptic

Indications & Usage

SINGLE USE WIPES FOR HANDS TO CLEAN & REMOVE ALLERGENS.

Warnings

FOR EXTERNAL USE ONLY.DO NOT REPLACE USED FOR MEDICAL PROCEDURES. THESE WIPES ARE MEANT FOR GENERAL CLEANSING.FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME. IF EYE CONTACT OCCURS, FLUSH EYES WITH WATER. STORE AT ROOM TEMPERATURE 59F-86F.

Otc - Stop Use

STOP USE: IF IRRITATION AND REDNESS DEVELOP. IF CONDITION CONTINUES, CONSULT YOUR HEALTH CARE PRACTITIONER.

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.

Inactive Ingredient

Water, Glycerin, Vitamin-E.

Directions

DIRECTIONS: UNFOLD TOWLETTE, WIPES HAND, DISCARD AFTER USE. FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION. NOT RECOMMENDED FOR INFANTS.

100Pcs All-Purpose Sanitizing Wipes

100pcs Sanitizing Wipes, NDC: 79650-100-75

* Please review the disclaimer below.