Hemotreat
FDA Label NDC 69758-328

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Global Treat Srl for the product Hemotreat (NDC 69758-328). 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 drug facts, active ingredients, purposes, uses, warnings, otc - do not use, stop use and ask a doctor if:, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts


Active Ingredients

DL-CAMPHOR (2.5%) wt/wt

Purposes

Analgesic

Uses

  • Helps relieve itching and discomfort associated with hemorrhoids and anorectal disorders
  • Temporarily relieves pain associated with anorectal inflammation and inflamed hemorrhoidal tissues
  • May provide cooling sensation

Warnings

For rectal use only

Otc - Do Not Use

Do not use for more than 30 consecutive days

When using this product do not exceed the recommended daily dosage, unless directed by a doctor

Stop Use And Ask A Doctor If:

  • Bleeding occurs
  • Condition worsens or does not improve within seven days
  • Signs of a local infection appear
  • Certain person can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside of if redness, irritation, swelling, pain, and or other symptoms develop or increase, discontinue use and consult a 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 the reach of children. If swallowed, get medical help or contact a poison Control Center right away 1 (800) 222-1222.

Children under 12 years: consult a doctor

Directions

Adults

  • When practical, cleanse the affected area with mild soap and warm water
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product.
  • Detach one suppository from the strip, remove the foil wrapper before inserting into the rectum as follows:
    • Hold suppository with rounded end up
    • Carefully separate foil tabs by inserting tip of fingernail at the end
    • Slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides to expose the suppository
    • Remove exposed suppository from wrapper
    • Insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement

Other Information

  • Store at 15-25°C (59-77°F)
  • Protect from excessive moisture
  • Keep away from direct sunlight

Inactive Ingredients

Aloe Vera Leaf Extract, Calendula Officinalis Extract, Achillea Millefolium Extract, Ethanol, Clove Oil, Witepsol H15, Phenoxyethanol, Ethylhexylglycerin, BHA

Otc - Questions

Manufactured by SC Global Treat SRL

157 Portului Street, 800211, Galati, Romania

Web: www.hemotreat.com

EMail: [email protected]

Questions? Call: 1 (800) 580-2238

Principal Display Panel

NDC 69758-328-88

HemoTreat

Hemorrhoidal Suppositories

Product Label (Hemotreat)

Product Label (Hemotreat)

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