Label: DR.CLINIC ANTIBACTERIAL HAND SANITIZER- ethyl alcohol gel

  • 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 30, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 73%

  • Purpose

    Antibacterial

  • 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

    • do not store in direct sunlight
    • store below 50°C/105°F
    • avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    carbomer, glycerin, triethanolamine, water

  • Question? +1-XXX-XXX-XXXX

    You may also report serious side effects to this number.

    Mon-Fri 9.00 AM - 5.00 PM

  • SPL UNCLASSIFIED SECTION

    MADE IN TURKEY

    Name and address of the owner of the manufacturer

    / Name and address of the license holder:

    MAKYAJ KOZMETIK IN‑AAT SANAYI TICARET LIMITED ‑IRKETI

    Hadımköy Baglantı Yolu Akçaburgaz Mah. Esenyurt / Istanbul

    info@makyajkozmetik.com.tr

  • Packaging

    IMAGEIMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    DR.CLINIC ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76725-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76725-101-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    2NDC:76725-101-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    3NDC:76725-101-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    4NDC:76725-101-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
    5NDC:76725-101-055000 mL in 1 CAN; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/05/2020
    Labeler - MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI (504546402)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAKYAJ KOZMETIK INSAAT SANAYI VE TICARET LIMITED SIRKETI504546402manufacture(76725-101)
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