Hemorrhoidal Pain Relief
Hemorrhoidal Pain Relief Cream
374dc1c0-4243-b272-e063-6394a90a5a6b
HUMAN OTC DRUG LABEL
Jun 11, 2025
Neilmed Pharmaceuticals Inc.
DUNS: 799295915
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hemorrhoidal Pain Relief Cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
Ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are:
Presently taking a prescription drug for high blood pressure or depression.
OTC - WHEN USING SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Drug Facts:
Active Ingredients
Glycerin 14.4%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
Petrolatum 15%
OTC - PURPOSE SECTION
Drug Facts:
Purpose
Protectant
Vasoconstrictor
Local Anesthetic
Protectant
WARNINGS SECTION
Warnings:
For external use only
OTC - ASK DOCTOR SECTION
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
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
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.
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
1 (877) 477-8633
TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING