FDA.reportPublic FDA data

MEDCLOT Hemostatic Dressing 7.5 cm x 7.5 cm

Manufacturer
Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V.
Effective date
2025-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:45

Label at a glance#

ProductMEDCLOT Hemostatic Dressing 7.5 cm x 7.5 cm
Active ingredientCARBOXYMETHYLCELLULOSE
Label structure12 sections

Storage and handling

Keep at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a HEMOSTATIC DRESSING - Sterile Dressing 7.5 cm x 7.5 cm

OTC - ACTIVE INGREDIENT SECTION

CarboxymethylCellulose

OTC - PURPOSE SECTION

Emergecy bleeding control.
For use by trained emergency responders.

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

More than one MED-CLOT may be required.

OTC - DO NOT USE SECTION

Do not use if package is damaged.

OTC - WHEN USING SECTION

Reuse will cause risk of infection and loss of efficacy.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Avoid contact with eyes.

STORAGE AND HANDLING SECTION

Keep at room temperature.

INACTIVE INGREDIENT SECTION

Purified water (standard ISO 13959:2014)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDCLOT 7.5 cm. x 7.5 cm.MEDCLOT 7.5 cm. x 7.5 cm.85925-201-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85925-201-01MEDCLOT Hemostatic Dressing 7.5 cm x 7.5 cm7.5 mL in 1 BOTTLEDRESSING7.51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85925-20185925-201-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE05JZI7B19XACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDCLOT Hemostatic Dressing 7.5 cm x 7.5 cmMEDCLOT HEMOSTATIC DRESSINGComercializadora y Distribuidora de Equipos y Frmacos, S.A. de C.V.3b0215ae-b106-d877-e063-6294a90a5dfe2025-07-28WarningsExact identifier
ndc (package): 85925-201-01
ndc (product): 85925-201
ndc11 (package): 85925020101
spl id: 3b0215ae-b107-d877-e063-6294a90a5dfe
spl set id: 3b0215ae-b106-d877-e063-6294a90a5dfe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.