NDC 78089-041 Sanitol London Sanitizing

Ethyl Alcohol

NDC Product Code 78089-041

NDC 78089-041-01

Package Description: 600 mL in 1 BOTTLE, SPRAY

NDC Product Information

Sanitol London Sanitizing with NDC 78089-041 is a a human over the counter drug product labeled by Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi. The generic name of Sanitol London Sanitizing is ethyl alcohol. The product's dosage form is aerosol, spray and is administered via topical form.

Labeler Name: Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi

Dosage Form: Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.

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.

Sanitol London Sanitizing 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.

  • BUTANE (UNII: 6LV4FOR43R)
  • PROPANE (UNII: T75W9911L6)
  • ISOBUTANE (UNII: BXR49TP611)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 78089
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: 09-04-2020 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.

Sanitol London Sanitizing Product Label Images

Sanitol London Sanitizing 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

Ethyl alcohol 75%

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin• recommended for repeated use• for use when soap and water are not available

Warnings

• Extremely flammable aerosol, keep away from fire / flame.• Keep away from heat, hot surfaces, open flames and other ignition sources.• Pressurized container. Do not pierce or burn even after use.• Protect from the sunlight.• For external use only.Do not use• on children less than 2 months of age• on open skin woundsWhen using this product • Avoid use on/or around eyes, ears, mouth, broken/irritated skin or largeareas of body. In case of contact with eyes, rinse thoroughly with water several minutes. • do notinhale or ingest.Stop and ask doctor if• irritation persist• or if product is swallowed

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

• Shake well before use.• Hold can upright at 6-7 inches away from surface and spray evenly.• Allow to air dry for 5 to 10 minutes. Repeat application a necessary• Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

• store between 15-30°C (59-86°F)• Do not expose to temperatures exceeding 50 C/122 F.

Inactive Ingredients

Butane, Propane, Isobutane, Parfum, Glycerin

* Please review the disclaimer below.