NDC 79391-101 Yugo Hand Sanitizer

Ethyl Alcohol

NDC Product Code 79391-101

NDC 79391-101-01

Package Description: 2 mL in 1 PACKET

NDC 79391-101-02

Package Description: 4 mL in 1 PACKET

NDC 79391-101-03

Package Description: 6 mL in 1 PACKET

NDC 79391-101-04

Package Description: 45 mL in 1 BOTTLE

NDC 79391-101-05

Package Description: 50 mL in 1 BOTTLE

NDC 79391-101-06

Package Description: 60 mL in 1 BOTTLE

NDC 79391-101-07

Package Description: 100 mL in 1 BOTTLE

NDC 79391-101-08

Package Description: 110 mL in 1 BOTTLE

NDC 79391-101-09

Package Description: 250 mL in 1 BOTTLE

NDC 79391-101-10

Package Description: 500 mL in 1 BOTTLE

NDC 79391-101-11

Package Description: 1000 mL in 1 BOTTLE

NDC 79391-101-12

Package Description: 5000 mL in 1 BOTTLE

NDC 79391-101-13

Package Description: 20000 mL in 1 CONTAINER

NDC Product Information

Yugo Hand Sanitizer with NDC 79391-101 is a a human over the counter drug product labeled by Silvia Kimya Urunleri Sanayi Ve Ticaret Limited Sirketi. The generic name of Yugo Hand Sanitizer is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Silvia Kimya Urunleri Sanayi Ve Ticaret Limited Sirketi

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Yugo Hand Sanitizer 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 64 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.

  • WATER (UNII: 059QF0KO0R)
  • 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: Silvia Kimya Urunleri Sanayi Ve Ticaret Limited Sirketi
Labeler Code: 79391
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: 07-03-2020 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’.

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Yugo Hand Sanitizer Product Label Images

Yugo Hand Sanitizer 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 64%

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin. Is an ideal hand cleaning product.

Warnings For External Use Only.

  • UndrinkableKeep away from children, food and animal feeds.When Using This ProductGeneral Recommendation: As a general rule, if an unexpected situation in encountered or symptoms persist, consult a doctor. Never try to induce vomiting unconscious person. Take the patient to fresh air. Keep calm and warm.By Inhalation: Move the injured person to fresh air and keep it in a comfortable position for easy breathing. If any discomfort continues, consult a doctor.In case of Skin Contact: In case of rash, burning or itching, wash with plenty of water and rinse. If irritation persists, do not use the product and consult your doctor.Eye Contact: Check and remove if you have contact lenses. In case of contact with eyes, wash the upper and lower covers occasionally for at least 15 minutes with plenty of water and consult a doctor immediately.Ingestion: Do not induce vomiting. Do not give anything by mouth in case of fainting. Call a doctor immediately and seek medical help. Antidote of product and necessary informations: No specific antidote that is known.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

The product is used in hands and palms as a dosage in public and personal areas. After cleaning the area to be applied with water and soap, take the product as much as necessary. Use by rubbing on the hands, including between the toes, the inside of the nails, all the inner and outer surfaces of the hand. There is no need to rinse.

Other Information

It is toxic for the bees. It can be harmful to fish and aquatic organisms. It is recommended that children use it under adult control. Avoid direct eye contact. Store in a cool, dry place where it does not get sunlight. Store upright in its original package.

Inactive Ingredients

Water, Thickener and Glycerin.

Other

ANTIBACTERIAL GELSANITIZING STRENGTHProduction date:Expiration date: Two years from the date of productionManufactured bySilvia Kimya Ürünleri San.Ve Tic.Ltd.Şti Yenibosna Merkez Mah. Yalçin Kores Cad. Maolya 1 sk. No:4 Bahçelievler/ISTANBULYenibosna V.D: 770 043 8446MADE IN TURKEY

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