Label: MEDCLOT HEMOSTATIC DRESSING 10 CM X 10 CM- medclot hemostatic dressing dressing

  • NDC Code(s): 85925-101-01
  • Packager: Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 28, 2025

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  • SPL UNCLASSIFIED SECTION

    This is a HEMOSTATIC DRESSING - Sterile Dressing 10 cm x 10 cm

  • ACTIVE INGREDIENT

    CarboxymethylCellulose

  • PURPOSE

    Emergecy bleeding control.

    For use by trained emergency responders.

  • INDICATIONS & USAGE

    1. Open package and remove MED-CLOT.

    2. Pack MED-CLOT into the wound and use it to apply pressure directly over bleeding source. More than one MED-CLOT may be required.

    3. Continue to apply pressure untill bleeding is under control.

    4. Wrap and tie bandage to maintain pressure. Seek medical care immediately. Show PRODUCT REMOVAL directions on package to medical personnel.

  • WARNINGS

    For external use only.

    Sterility not guaranteed if package is damaged.

    Avoid contact with eyes.

    Reuse will cause risk of infection and loss of efficacy.

  • DOSAGE & ADMINISTRATION

    More than one MED-CLOT may be required.

  • DO NOT USE

    Do not use if package is damaged.

  • WHEN USING

    Reuse will cause risk of infection and loss of efficacy.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Avoid contact with eyes.

  • STORAGE AND HANDLING

    Keep at room temperature.

  • INACTIVE INGREDIENT

    Purified water (standard ISO 13959:2014)

  • PRINCIPAL DISPLAY PANEL

    85925-101-01 MED-CLOT 10 cm. x 10 cm.

  • INGREDIENTS AND APPEARANCE
    MEDCLOT HEMOSTATIC DRESSING 10 CM X 10 CM 
    medclot hemostatic dressing dressing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85925-101
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE0.002 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85925-101-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2025
    Labeler - Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V. (951637153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V.951637153manufacture(85925-101)