Label: DETROX - DETRODERM GEL HAND AND SKIN ANTISEPTIC- isopropyl alcohol gel

  • NDC Code(s): 79506-101-01, 79506-101-02, 79506-101-03, 79506-101-04, view more
    79506-101-05
  • Packager: DETRO HEALTHCARE KIMYA SANAYI ANONIM 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 24, 2020

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  • Drug Facts

  • Active ingredient

    %70 Isopropyl Alcohol

  • Purpose

    Antiseptic

  • Uses

    Hygienic and surgical antisepsis of hands and skin. It is used at all health institutions like surgery, intensive care, clinics, dental clinics, laboratory, veterinary, patient care at home.

  • Warnings

    Flammable. Keep out of ignition sources directly.

    Do not use
    Before reading user manual
    After 6 months from cover opening

    When using this product
    No smoking. must not be contacted with powerful oxidants, alkali metals due to fire and explosion possibility. Keep out of reach of children, food, and animal foods. Keep out of ignition sources directly. Do not stock with oxidant and spontaneously combustible materials. Obey instructions existed in user manual.

    Stop use and ask a doctor if

    *In case of poisoning

    *In case of ingestion

    *In case of contact with eyes

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

  • Directions

    For hygienic hand antisepsis, at least 3 ml solution is applied to hand without dilution and hands are rubbed until drying. For surgical hand antisepsis, 5 ml solution is applied to hand.

  • Other Information

    Store containers tightly closed and in a well-ventilated area between 0 – 30°C and away from direct sunlight.

    Do not use after expiry date.

  • Inactive ingredients

    1,3-butanediol, glycerin, essence, carbomer, deionized water

  • Questions

    You may also report serious side effects to this phone number (+1-XXX-XXX-XXXX)

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

  • SPL UNCLASSIFIED SECTION

    • Wide Effect Spectrum

    • Alcohol Based

    • Extensive Skin Compatability

    • Usable at Dispenser

    Email: international@detrox.com.tr

    MADE IN TURKEY

    Producer Name and Address:

    Detro Healthcare Kimya Sanayi A.S.

    Atatürk mh. Adnan Menderes cd.

    No:7 Esenyurt/Istanbul-Turkey

  • Packaging

    Detrox101

  • INGREDIENTS AND APPEARANCE
    DETROX  - DETRODERM GEL HAND AND SKIN ANTISEPTIC
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79506-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79506-101-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    2NDC:79506-101-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    3NDC:79506-101-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    4NDC:79506-101-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    5NDC:79506-101-055000 mL in 1 CAN; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207)
    Establishment
    NameAddressID/FEIBusiness Operations
    DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI533133207manufacture(79506-101)
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