MedPath

Hemorrhoidal Pain Relief

Hemorrhoidal Pain Relief Ointment

Approved
Approval ID

374d89b6-9305-9adf-e063-6394a90adb32

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 11, 2025

Manufacturers
FDA

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 Ointment

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13709-334
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hemorrhoidal Pain Relief Ointment
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 11, 2025
FDA Product Classification

INGREDIENTS (16)

PETROLATUMActive
Quantity: 749 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
THYMUS VULGARIS (THYME) OILInactive
Code: 2UK410MY6B
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MINERAL OILActive
Quantity: 140 mg in 1 g
Code: T5L8T28FGP
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 g
Code: 04JA59TNSJ
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
LANOLIN ALCOHOLInactive
Code: 884C3FA9HE
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/12/2025

Hemorrhoidal Ointment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/12/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/12/2025

Drug Facts

Active Ingredients:

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/18/2025

Drug Facts:

Purpose

Protectant

Protectant

Vasoconstrictor

WARNINGS SECTION

LOINC: 34071-1Updated: 6/12/2025

Warnings:

For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/12/2025

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

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 6/12/2025

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

LOINC: 50567-7Updated: 6/12/2025

When using this product:

  • Do not exceed the recommended daily dosage unless directed by a doctor

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/12/2025

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 6/12/2025

If pregnant or breast-feeding:

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/12/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/12/2025

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 SAFETY INFORMATION

LOINC: 60561-8Updated: 6/12/2025

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

LOINC: 51727-6Updated: 6/12/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/12/2025

Questions or comments?

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Hemorrhoidal Pain Relief - FDA Drug Approval Details