Label: ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     78433-101-01, 78433-101-02, 78433-101-03, 78433-101-04, view more
    78433-101-05, 78433-101-06, 78433-101-07, 78433-101-08, 78433-101-09, 78433-101-10, 78433-101-11, 78433-101-12
  • Packager: KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
  • Category: HUMAN OTC DRUG LABEL

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 7, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%

  • 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

    Flammable, keep away from fire/flame

    For external use only

    Do not use

    ▪ in children less than 2 months of age

    ▪ on open skin wounds

    When using this product

    ▪ do not get into eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    ▪ irritation and redness develop

    ▪ condition persists for more than 72 hours

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

  • Directions

    ▪ wet hands thoroughly with product and allow to dry without wiping

    ▪ supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    ▪ store between 15-30°C (59-86°F)

    ▪ avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredients

    carbomer, glycerin, water

  • Questions?

    +1-410-441-4610

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

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

  • SPL UNCLASSIFIED SECTION

    Quality in our chemistry

    Empty packaging way of dispose: Properly dispose of accordance the rule.

    Ministry of Health License Date and Number 27.03.2020-202079

    Manufactured for:

    KOÇKAR

    Makina Kimya San. ve Tic. A.S.

    Fatih Mh. 9008 Sk. No: 121

    AkyazI, SAKARYA, TURKEY 54400

    COUNTRY OF ORIGIN: TURKEY

    www.wieberr.com.tr / info@wieberr.com.tr

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78433-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78433-101-015 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    2NDC:78433-101-0210 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    3NDC:78433-101-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    4NDC:78433-101-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    5NDC:78433-101-05200 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    6NDC:78433-101-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    7NDC:78433-101-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    8NDC:78433-101-08750 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    9NDC:78433-101-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    10NDC:78433-101-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
    11NDC:78433-101-1120000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/07/2020
    12NDC:78433-101-121000000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2020
    Labeler - KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI (533111210)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI533111210manufacture(78433-101)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!