Other
This is a HEMOSTATIC DRESSING - Sterile Dressing 10 cm x 10 cm
Medclot Hemostatic Dressing 10 Cm X 10 Cm Dressing
FDA Label NDC 85925-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Comercializadora Y Distribuidora De Equipos Y F�rmacos, S.a. De C.v. for the product Medclot Hemostatic Dressing 10 Cm X 10 Cm (NDC 85925-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
CarboxymethylCellulose
Otc - 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.
Otc - Do Not Use
Do not use if package is damaged.
Otc - When Using
Reuse will cause risk of infection and loss of efficacy.
Otc - 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)
Package Label.Principal Display Panel
85925-101-01
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