FDA Label for Hemorrhoidal Pain Relief
View Indications, Usage & Precautions
- DRUG FACTS
- DRUG FACTS:
- USES:
- WARNINGS:
- ASK A DOCTOR BEFORE USE IF YOU HAVE:
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE:
- WHEN USING THIS PRODUCT:
- STOP USE AND ASK DOCTOR IF:
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS OR COMMENTS?
- IMPORTANT:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Hemorrhoidal Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals Inc.. 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:
Mineral Oil 14%
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Drug Facts:
Purpose
Protectant
Protectant
Vasoconstrictor
Uses:
- Helps relieve the local itching and discomfort associated with hemorrhoids
- Temporarily shrinks hemorrhoidal tissue and relieves burning
- Temporarily provides a coating for relief of anorectal discomforts
- Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings:
For external and/or intrarectal use only
Ask A Doctor Before Use If You Have:
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Difficulty in urination due to enlargement of prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are:
Presently taking a prescription drug for high blood pressure or depression
When Using This Product:
- Do not exceed the recommended daily dosage unless directed by a doctor
Stop Use And Ask Doctor If:
- Bleeding occurs
- Condition worsens or does not improve within 7 days
- Introduction of applicator into the rectum causes additional pain
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: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
- When first opening the tube, puncture foil seal with top end of cap.
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- Intrarectal use: Remove cover from the applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover.
- Also apply ointment to external area.
- Regular use provides continual therapy for relief of symptoms.
Other Information:
Store at 15°C – 30°C (59°F – 86°F)
- Children under 12 years of age: ask a doctor
Inactive Ingredients:
Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol, acetate, white wax
Questions Or Comments?
1 (877) 477-8633
TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
Important:
Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.
* Please review the disclaimer below.
