NDC 80192-204 Theruptor

Wipes-70ea

NDC Product Code 80192-204

NDC 80192-204-02

Package Description: 50 PACKAGE in 1 PACKAGE > 350 mL in 1 PACKAGE

NDC Product Information

Theruptor with NDC 80192-204 is a a human over the counter drug product labeled by Carenow Medical Pvt Ltd. The generic name of Theruptor is wipes-70ea. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Carenow Medical Pvt 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.

Theruptor 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 70 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)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Carenow Medical Pvt Ltd
Labeler Code: 80192
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: 09-03-2020 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.

Theruptor 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:

Ethanol denatured equivalent to Ethanol 70% v/v

Purpose

Antiseptic

Uses:

  • Indicated for rapid hand disinfection and sanitization.Recommended for repeated use.

Warnings:

For external Use onlyFlammable. Keep away from heat or flame.
Do not use: In children less than 2 months of age or on open skin wounds. Supervise children under 6 years of age when using this product.

Otc - Stop Use

Stop use and ask doctor if irritation or rash occurs, conditions persists for more than 72 hours.

Otc - Keep Out Of Reach Of Children

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

Direction Of Use:

  • Open the canister cap and pull a wipeKeep package tightly closed. Wet hands thoroughly with product and allow to dry.Residual alcohol should be emptied prior to disposing. Dispose wipes and package in accordance with local regulationOnce opened, keep canister tightly closed.

Inactive Ingredient:

Glycerine, Fragrance and purified water.Size of Wipe : 15 x 20cm

Other Information:

  • Store below 110°F (43°C)Proven Anti-microbial Efficacy - provides rapid bactericidal action against a broad spectrum of micro organisms.
  • Skin Antiseptic formula with a combination of alcohol and skin emollients for effective bactericidal, fungicidal & Viricidal activity.
  • Moisturized with skin emollients to prevent skin dryness and damage.

* Please review the disclaimer below.