Drug Facts:
Active Ingredients
Glycerin 14.4%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
Petrolatum 15%
Purpose
Protectant
Vasoconstrictor
Local Anesthetic
Protectant
Hemorrhoidal Pain Relief Cream
FDA Label NDC 13709-335
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Hemorrhoidal Pain Relief (NDC 13709-335). 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:, 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- For temporary relief from pain and burning
- Helps relieve local itching and discomfort associated with hemorrhoids
- Temporarily shrinks hemorrhoidal tissue
- 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 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.
- Do not put in the rectum by using fingers or any mechanical device or applicator.
Stop Use And Ask Doctor If:
- Bleeding occurs
- Condition worsens or does not improve within 7 days
- An allergic reaction occurs
- The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
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 cream.
- When first opening the tube, puncture foil seal with top end of cap.
- Apply externally or in the lower portion of the anal canal only.
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- For application in the lower anal canal: Remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well using cream from the tube, then gently insert dispensing cap partway into anus. Thoroughly cleanse dispensing cap after each use and replace cover.
- Children under 12 years of age: ask a doctor.
Other Information:
Store at 15°C – 30°C (59°F – 86°F)
Inactive Ingredients:
Aloe vera leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate
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.
