Active Ingredients
Menthol 0.44%
White Petrolatum 66.335%
Zinc Oxide 20.625%
Procure Clamaplex Ointment
FDA Label NDC 55681-044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Twin Med Llc for the product Procure Clamaplex (NDC 55681-044). 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 ingredients, purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol 0.44%.........................................Analgesic
White Petrolatum 66.335%...............................Protectant
Zinc Oxide 20.625%............Astringent / Protectant
Uses
- gives temporary relief of local itching and discomfort in the perianal area
- temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
- temporarily protects irritated areas
- temporarily relieves burning
- provides temporary relief from skin irritations
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
- temporarily protects inflamed perianal skin
- temporarily relieves the symptoms of perianal skin irritation
- may provide a cooling sensation
Warnings
Warnings
For external use only
Allergy Alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
When Using This Product
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask Doctor If
Stop using and ask a doctor if
- condition worsens or does not improve in 7 days
- bleeding occurs, consult a doctor promptly
Keep Out Of Reach Of Children
Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.
Directions
Directions
- Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to affected area up to 6 times daily.
- Children under 12 years of age: consult a doctor
Inactive Ingredients
Inactive Ingredients: Calamine, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol
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