FDA Label for Hemorrhoidal
View Indications, Usage & Precautions
Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Geritrex Llc. 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.
Active Ingredient Purposemineral Oil - 14% Protectantpetrolatum - 71.9% Protectantphenylephrine - 0.25% Astringent
Uses:
- Helps relieve local itching and discomfort with hemorrhoids.
- Temporarily shrinks hemorrhoid tissues and relieves burning.
- Temporarily provides a coating for relief of anorectal discomforts
- Temporarily protects the inflamed, irritated anorectal surface to hlep make bowel movements less painful
Warnings:
For external and/or intrarectal use only
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 7 days
- Introduction of the applicator into the rectum causes additional pain
Directions:
- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.
- Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment
- Apply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- Remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.
- Thoroughly cleanse applicator after each use
- Also apply ointment to external area
- Regular use provides continual therapy for relief of symptoms
- Children under 12 years of age, consult a doctor
For Intrarectal use
Other Information:
Store at room temperature but not over 80° F
Lot No. & Exp Date: See tube
Inactive Ingredients:
Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.
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