Thera Wise Natural Hemorrhoidal Ointment
FDA Label NDC 43347-158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma Wise Skin Care Ltd. for the product Thera Wise Natural Hemorrhoidal (NDC 43347-158). 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, active ingredient, purpose, uses, warnings, otc - do not use, stop use and consult a doctor if:, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Allergy alert: contains Asteracea (daisy) plant material

Active Ingredient

Witch Hazel 12%

Purpose

Astringent / Anti-inflammatory

Uses

  • For the temporary relief of anorectal discomfort associated with hemorrhoids
  • For the temporary relief of local itching associated with hemorrhoids

Warnings

For rectal and external use only

Otc - Do Not Use

Do not use this product with the applicator if the introduction of the applicator into the rectum causes additional pain.

Consult a doctor promptly.

Stop Use And Consult A Doctor If:

  • Condition worsens or does not improve within 7 days
  • Bleeding occurs

Otc - When Using

When using this product do not exceed the recommended daily dosage unless directed by your doctor.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • When first opening, tear away safety seal.
  • Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / or
  • pat and blot with appropriate cleansing pad.
  • Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.
  • FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube.
  • Lubricate applicator well, then gently insert applicator into the rectum.
  • Thoroughly cleanse applicator after each use and replace cover.
  • Apply to the affected area up to 6 times daily or after each bowel movement.
  • Children under 12 years of age: consult a doctor.

Other Information

  • Store between 2° and 25° C (35° - 77° F)
  • Do not use if seal is broken

Inactive Ingredients

Aloe Vera Extract

Certified Organic

, Argan Kernel Oil, Butcher's Broom Extract, Cetearyl Olivate, Chamomile Flower Extract, Citric Acid, Dehydroacetic Acid, Glycerin, Grape Seed Oil, Hydrogenated Olive Oil, Oat Beta Glucan, Olive Oil, Olive Oil Unsaponifiables Olive Squalane, Seabuckthorn Fruit Oil, Sclerotium Gum, Shea Butter, Sodium Anisate, Sodium Levulinate, Sorbitan Olivate, Sodium Steroyl Glutamate, Stearyl Alcohol, Sunflower Seed Oil, Tocopherols, Water

Questions Or Comments?

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Principal Display Panel - 28 G Tube Box

Natural Hemorrhoidal Ointment

12 % WITCH HAZEL
For the temporary relief of itching and
discomfort associated with hemorrhoids

THÉRA WISE®

WITH BUTCHER'S BROOM, WITCH HAZEL, CHAMOMILE
& ALOE LEAF EXTRACT, OAT PREBIOTIC,
GRAPE SEED, SEABUCKTHORN & ARGAN OIL

NEW WT 1OZ (28g)

Principal Display Panel (28 g Tube Box)

Principal Display Panel (28 g Tube Box)

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