MEDCLOT HEMOSTATIC DRESSING 7.5 CM X 7.5 CM- medclot hemostatic dressing dressing

MEDCLOT Hemostatic Dressing 7.5 cm x 7.5 cm by

Drug Labeling and Warnings

MEDCLOT Hemostatic Dressing 7.5 cm x 7.5 cm by is a Otc medication manufactured, distributed, or labeled by Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

85925-201-01

INGREDIENTS AND APPEARANCE

MEDCLOT HEMOSTATIC DRESSING 7.5 CM X 7.5 CM 
medclot hemostatic dressing dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85925-201
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE	0.002 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85925-201-01	7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2025

Labeler - Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V. (951637153)

Establishment
Name	Address	ID/FEI	Business Operations
Comercializadora y Distribuidora de Equipos y Fármacos, S.A. de C.V.		951637153	manufacture(85925-201)