NDC 79506-100 Detrox Detroderm Hand And Skin Antiseptic

Isopropyl Alcohol

NDC Product Code 79506-100

NDC 79506-100-01

Package Description: 100 mL in 1 BOTTLE

NDC 79506-100-02

Package Description: 250 mL in 1 BOTTLE

NDC 79506-100-03

Package Description: 500 mL in 1 BOTTLE

NDC 79506-100-04

Package Description: 1000 mL in 1 BOTTLE

NDC 79506-100-05

Package Description: 5000 mL in 1 CAN

NDC Product Information

Detrox Detroderm Hand And Skin Antiseptic with NDC 79506-100 is a a human over the counter drug product labeled by Detro Healthcare Kimya Sanayi Anonim Sirketi. The generic name of Detrox Detroderm Hand And Skin Antiseptic is isopropyl alcohol. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 808520.

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.

Detrox Detroderm Hand And Skin Antiseptic 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.


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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • 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.

Product Labeler Information

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

Labeler Name: Detro Healthcare Kimya Sanayi Anonim Sirketi
Labeler Code: 79506
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: 06-30-2020 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 - 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.

Detrox Detroderm Hand And Skin Antiseptic Product Label Images

Detrox Detroderm Hand And Skin Antiseptic 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

%70 Isopropyl Alcohol

Purpose

Antiseptic

Uses

Hygienic and surgical antisepsis of hands and skin. It is used at all health institutions like surgery, intensive care, clinics, dental clinics, laboratory, veterinary, patient care at home.

Warnings

Flammable. Keep out of ignition sources directly.Do not useBefore reading user manualAfter 6 months from cover openingWhen using this productNo smoking. must not be contacted with powerful oxidants, alkali metals due to fire and explosion possibility. Keep out of reach of children, food, and animal foods. Keep out of ignition sources directly. Do not stock with oxidant and spontaneously combustible materials. Obey instructions existed in user manual.Stop use and ask a doctor if*In case of poisoning*In case of ingestion*In case of contact with eyes

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.

Directions

For hygienic hand antisepsis, at least 3 ml solution is applied to hand without dilution and hands are rubbed until drying. For surgical hand antisepsis, 5 ml solution is applied to hand.

Other Information

Store containers tightly closed and in a well-ventilated area between 0 – 30°C and away from direct sunlight. Do not use after expiry date.

Inactive Ingredients

1,3-butanediol, glycerin, essence, deionized water

Questions

You may also report serious side effects to this phone number (+1-XXX-XXX-XXXX)Mon-Fri 9:00 AM - 5:00 PM

* Please review the disclaimer below.