Label: DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC- alcohol gel

  • NDC Code(s): 79506-103-01, 79506-103-02, 79506-103-03, 79506-103-04, view more
    79506-103-05, 79506-103-06
  • 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 April 20, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    %80 (V/V) Ethanol

  • Purpose

    Antiseptic

  • Uses

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

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, glycerin, triethanolamine, essence, 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 Compatibility

    • Usable at Dispenser

    Email: international@detrox.com.tr

    MADE IN TURKEY

    detrox®

    Integrated Disinfection Solutions

    Producer Name and Address:

    Detro Healthcare Kimya Sanayi A.S.

    Ataturk mh. Adnan Menderec cd.

    No:7 Esenyurt/Istanbul-Turkey

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    DETRODERM SOFT GEL HAND AND SKIN ANTISEPTIC 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79506-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79506-103-015000 mL in 1 CONTAINER; Type 0: Not a Combination Product04/15/2021
    2NDC:79506-103-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
    3NDC:79506-103-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
    4NDC:79506-103-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
    5NDC:79506-103-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
    6NDC:79506-103-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2021
    Labeler - DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI (533133207)
    Establishment
    NameAddressID/FEIBusiness Operations
    DETRO HEALTHCARE KIMYA SANAYI ANONIM SIRKETI533133207manufacture(79506-103)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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