NDC 74438-070 Weclean C2 Tlcuo

Peroxy Acetic Acid

NDC Product Code 74438-070

NDC 74438-070-01

Package Description: 650 mL in 1 BOTTLE

NDC Product Information

Weclean C2 Tlcuo with NDC 74438-070 is a a human over the counter drug product labeled by Ktl Ltd. The generic name of Weclean C2 Tlcuo is peroxy acetic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ktl 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.

Weclean C2 Tlcuo 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.

  • PERACETIC ACID .26 g/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.

  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ktl Ltd
Labeler Code: 74438
Marketing Category: UNAPPROVED DRUG OTHER - 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: 10-01-2020 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 - 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.

Weclean C2 Tlcuo Product Label Images

Weclean C2 Tlcuo 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

Peroxy acetic acid 0.26%

Inactive Ingredient

Water

Purpose

SANITIZER, ANTISEPTIC, Deodorant

Warnings

1.Do not use the product on the following areas:Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.If symptoms such as rash, itching, edema, and skin irritation occur, please stop using it.3.Other precautions1) For external use only (do not swallow).2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.3)Do not use in anal or vaginal areas as they may cause irritation.4) Use only for the intended purposes.4.Precautions for storage1) Keep away from direct sunlight and do not expose the product to heating devices or flame.2) Keep out of reach of children and go to the hospital immediately if swallowed.3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Keep Out Of Reach Of Children

Keep out of reach of children and go to the hospital immediately if swallowed.

Uses

Disinfection of Human’s hands and skin weclean C2 TLcuo, made of active peracetic acid,(PAA) is an effective sterilizing agent for bacillus, viruses, bacteria, etc. as well as odor removal for Human Body

Directions

Take an appropriate amount on your hands and rub thoroughly to dry.Rub evenly over areas of your hands or feet to dry naturally. For infants, the skin is weak and sensitive, preferably not to be used.

* Please review the disclaimer below.