Terramed Just Think Comfort Hemorrhoid Fissure Treatment Ointment
FDA Label NDC 83004-021

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Hemorrhoid Fissure Treatment (NDC 83004-021). 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, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Aesculus hippocastanum 7X HPUS (0.01 g)........................Reduces swelling and relieves stinging pain associated with external hemorrhoids                                                                                                           

Hamamelis virginiana 2X HPUS (0.01 g)............................................Relieves burning, itching, and discomfort associated with hemorrhoids

Paeonia officinalis (Peony) 2X H PUS (0.01 g)........................................Relieves burning pain and cozing associated with external hemorrhoids

Ratanhia 7X HPUS (0.01 g)................................................................Relieves itching and discomfort from external hemorrhoids,

                                                                                                         especially during and after bowel movements

Uses

Temporarily Relives symptoms of hemorrhoids such as:
• Burning
• Itching
• Swelling
• Pain
• Discomfort
• Relives hemorrhoids symptoms
following childbirth

Warnings

  • For rectal use only.
  • Ask a doctor before usein case of bleeding.
  • When using this product, do not exceed the recommended daily dosage unless directed by a doctor.
  • Stop use and ask a doctor ifsymtoms persist for more than 7 days or worsen.

Directions

Step 1 - Cleanse: Thoroughly wash the affected area with mild soap and warm water. Pat dry gently with a clean, soft cloth.

Step 2 - Preparation: Open the Recral pre-filled applicator packaging and remove the applicator. Hold it upright with the cap on.

Step 3- Unscrew Cap: Unscrew the cap gently from the pre-filled applicator. Make sure not to squeeze the tube during this process.

Step 4- Positioning: Gently and carefully insert the rounded tip of the applicator into the rectum, following the natural curvature.

Step 5- Application: Squeeze the applicator gently to dispense the recommended dose of the treatment. Slowly withdraw the applicator

                              while continuing to apply the treatment.

Step 6 - Dispose: After use, discard the applicator and cap in a suitable waste bin. Do not flush the applicator down the toilet.

Step 7 - Hygiene: Cleanse your hands thoroughly with soap and water after use.

Other Information

If you experience any discomfort, irritation, or adverse reactions during or after use, discontinue use and consult a healthcare professional. Do not use if tamper-evident seal is broken or missing. Keep out of reach of children.

Inactive Ingredients

Lanolin, Glyceryl Stearate, Petrolatum, Cetearyl Alcohol, Hydrogenated Castor Oil, Glycerin, Menthol, Eucalyptus Globulus (Eucalyptus) Oil, Tea Tree Oil, Linalool

Product Label

Image Description (Image 21)

Image Description (Image 21)

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