Terramed Just Think Comfort Hemorrhoidal Wipes Cloth
FDA Label NDC 83004-039

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 Hemorrhoidal Wipes (NDC 83004-039). 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, 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                                                    Purpose

Lidocaine 5% (w/w)                                             Local anesthetic
Phenylephrine HCl 0.25% (w/w)                            Vasoconstrictor               

Uses

  • For the temporary relief of pain, soreness, burning, and itching associated with hemorrhoids.
  • Temporarily relieves the inflamed tissue and reduces the swelling associated with hemorrhoidal tissue.
  • Temporarily provides a cooling sensation for relief of anorectal discomfort.

Warnings

For external use only.

Do not use:
• in or near the mouth
• in the eyes
• if you are allergic to lidocaine, phenylephrine, or any ingredients in this product

Ask a doctor before use if you have:
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urination due to enlargement of the prostate gland
• bleeding from the rectum

Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Phenylephrine may interact with certain prescription drugs.

When using this product:
• wash hands after use
• avoid contact with the eyes; if eye contact occurs, rinse thoroughly with water
• do not exceed recommended dose
• do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if:
• bleeding occurs
• the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
• condition worsens or does not improve within 7 days
• an allergic reaction develops

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and children 12 years of age and older:
• 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 applying the wipe
• unfold one wipe and gently apply to the affected area by patting, then discard
• apply externally to the affected area up to 6 times daily
Children under 12 years of age: ask a doctor.

Other Information

• Store at 20–25 °C (68–77 °F); excursions permitted to 15–30 °C (59–86 °F).
• Do not use if blister seal is broken or torn.
• Do not use if outer carton seal is broken or missing.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anhydrous Citric Acid, Edetate Disodium, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate.

Product Label

Image Description (Image 39)

Image Description (Image 39)

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