Label: MEDISEPTIC ANTINFECTANT- benzalkonium chloride liquid

  • 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 May 26, 2020

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

  • Mediseptic

    Application:

    Apply approx. 3-5ml of undiluted product into hollow hands and rub in. In particular take into account thumbs and fingertips, as they have most frequent contact with contaminated surfaces and objects.

    Frequency: Repeat as needed, to renew two hour long term protection.

    Application time: 1 minute

  • Mediseptic

    Inactive Ingredients:

    Water

    Organic acids

    ORganic polymers

    Glycerin

  • MediSeptic

    Use:

    Hygienic hand disinfection

    Use disinfectant safely. Always read label and product information before use.

  • Mediseptic

    Active Ingredient:

    Benzalkonium chloride ....0.1% ............antibacterial

  • Mediseptic

    Safety information:

    • Keep out of reach of children.

  • PURPOSE

    Purpose:

    antimicrobial

    for hand sanitizing

  • Mediseptic

    Warnings

    For external use only.

    Keep out of reach of children.

    Not for food use.

    Do not ingest.

  • Mediseptic

    • Keep out of reach of children.

    • Do not mix with acids and alkalis.

    • Store below 30C/86F.

    • Dispose of empty container in accordance with local regulations.

    • Safety data sheet available upon request.

    • Keep container tightly closed after use and keep cool.

  • MediSeptic Anitinfectant

    MediSeptic

    protect yourself everyday

    Anti Infectant Spray

    for hygienic hand disinfection in accordance with DIN EN 1500

    120 Min. Long-Term Efficacy

    • Continuous protection for 2 hours

    • Proven efficacy against bacteria and viruses (99.999%)

    • Skin-friendly and alcohol-free

    Use:

    Hygienic hand disinfection

    Application:

    Apply approx. 3-5ml of undiluted product into hollow hands and rub in. In particular take into account thumbs and fingertips, as they have the most frequent contact with contaminated surfaces and objects.

    Frequency: Repeat as needed, to renew two-hour long term protection.

    Application time: 1 minute

    Safety information:

    • Keep out of reach of children.

    • Do not mix with acids and alkalis.

    • Store below 30C/86F.

    • Dispose of empty container in accordance with local regulations.

    • Safety data sheet available upon request.

    • Keep container tightly closed after use and keep cool.

    Non-hazardous substance according to CLP-regulation

    Alcohol-free

    Non-toxic

    Without surfactants and aldehydes

    Non-flammable

    Use disinfectant safely. Always read label and product information before use.

    A50 Label

  • INGREDIENTS AND APPEARANCE
    MEDISEPTIC ANTINFECTANT 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71315-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) 0.25 g  in 100 g
    POVIDONE K15 (UNII: E54VE15114) 0.24 g  in 100 g
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) 0.01 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.9 g  in 100 g
    WATER (UNII: 059QF0KO0R) 98.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71315-800-50500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    2NDC:71315-800-10100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    3NDC:71315-800-25250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    4NDC:71315-800-0110 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
    5NDC:71315-800-0550 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Katan Technologies USA, LLC (063773754)