FDA Label for Hemotreat

View Indications, Usage & Precautions

Hemotreat Product Label

The following document was submitted to the FDA by the labeler of this product Global Treat Srl. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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