Label: YUGO HAND SANITIZER- ethyl alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     79391-101-01, 79391-101-02, 79391-101-03, 79391-101-04, view more
    79391-101-05, 79391-101-06, 79391-101-07, 79391-101-08, 79391-101-09, 79391-101-10, 79391-101-11, 79391-101-12, 79391-101-13
  • Packager: SILVIA KIMYA URUNLERI SANAYI VE TICARET LIMITED SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 3, 2020

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  • Drug Facts

  • 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.

    • Undrinkable
    • Keep away from children, food and animal feeds.

    When Using This Product
    General 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.

    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.

  • Questions or comments?

    1-866-695-3030

    You may also report serious side effects to this phone number.

    (Mon-Fri 9:AM - 5:00 PM)

  • SPL UNCLASSIFIED SECTION

    ANTIBACTERIAL GEL

    SANITIZING STRENGTH

    Production date:

    Expiration date: Two years from the date of production

    Manufactured by

    Silvia Kimya Ürünleri San.Ve Tic.Ltd.Şti Yenibosna Merkez Mah. Yalçin Kores Cad. Maolya 1 sk. No:4 Bahçelievler/ISTANBUL

    Yenibosna V.D: 770 043 8446

    MADE IN TURKEY

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    YUGO  HAND SANITIZER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79391-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL64 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79391-101-012 mL in 1 PACKET; Type 0: Not a Combination Product07/03/2020
    2NDC:79391-101-024 mL in 1 PACKET; Type 0: Not a Combination Product07/03/2020
    3NDC:79391-101-036 mL in 1 PACKET; Type 0: Not a Combination Product07/03/2020
    4NDC:79391-101-0445 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    5NDC:79391-101-0550 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    6NDC:79391-101-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    7NDC:79391-101-07100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    8NDC:79391-101-08110 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    9NDC:79391-101-09250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    10NDC:79391-101-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    11NDC:79391-101-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    12NDC:79391-101-125000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2020
    13NDC:79391-101-1320000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/03/2020
    Labeler - SILVIA KIMYA URUNLERI SANAYI VE TICARET LIMITED SIRKETI (533133969)
    Establishment
    NameAddressID/FEIBusiness Operations
    SILVIA KIMYA URUNLERI SANAYI VE TICARET LIMITED SIRKETI533133969manufacture(79391-101)
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