Active Ingredient
Petrolatum (93.3%)
Hemo Fin
FDA Label NDC 50211-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd Merc Llc for the product Hemo Fin (NDC 50211-001). 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 active ingredient, purpose, uses, warnings, do not use, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hemorrhoidal ointment
Uses
• Provides temporary relief from skin irritations• Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues• Temporarily protects irritated areas• Temporarily relieves burning• Temporarily provides a coating for relief of anorectal discomforts• Temporarily protects the inflamed, irritated, anorectal surface from irritation and abrasion during bowel movement• Temporarily protects inflamed perianal skin• Temporarily relieves symptoms of perianal skin irritation
Warnings
For external and/or intrarectal use only
If condition worsens or does not improve within 7 days, consult a physician
Do not exceed the recommended daily dosage unless directed by a doctor
In case of bleeding, consult a physican promptly
Do Not Use
this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing wipe before applying ointment.• Apply liberally to affected area as often as necessary.• Intrarectal Use: attach applicator to tube, lubricate applicator well and gently insert applicator into rectum. Thoroughly cleanse applicator after each use.
Inactive Ingredients
Aloe Vera, Iodine, Okra, Oleic Acid, Sage
For Questions Or Comments:
PDmerc.com
Distributed By
P D Merc, LLC
1581 W 49th St #191
Hialeah, FL 33012
NDC 50211-001-01
Package Label.Principal Display Panel
Hemo-Fin
Hemorrhoidal Oitment
Net Wt. 1 oz. (28 g)
HemoFin20120910.jpg
Hemo Fin Hemorrhoidal Ointment R1 (Hemofin20120910)
HemoFin20120910.jpg
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