Drugplain

Hemorrhoidal 14 g/100g

mineral oil, petrolatum, phenylephrine HCl · OINTMENT · Proficient Rx LP

7 Recalls on Record
Plain English

Hemorrhoidal is a ointment containing mineral oil, petrolatum, phenylephrine hcl at 14 g/100g, taken rectal. Manufactured by Proficient Rx LP.

Key Facts

Brand Name
Hemorrhoidal
Generic Name
mineral oil, petrolatum, phenylephrine HCl
NDC Code (Product)
63187-505
Manufacturer
Proficient Rx LP
Strength
14 g/100g
Dosage Form
OINTMENT
Route
RECTAL
Marketing Status
Application #
M015
Marketing Start
11/01/2013

Recall History

7 Recalls on Record
Class III03/07/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

TerminatedVoluntary: Firm initiated
Class II01/27/2017

Cherry Hill Sales Co.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class III02/17/2023

Akron Pharma, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,760 reports
pain3,461 reports
fatigue3,157 reports
nausea3,136 reports
headache2,919 reports
off label use2,712 reports
dyspnoea2,238 reports
diarrhoea2,023 reports
pneumonia2,014 reports
sinusitis1,951 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Dosage & Administration

Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years of age: consult a doctor.

Warnings

For external use only. Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the 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 : avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if : rectal bleeding occurs, condition worsens or does not improve within seven (7) days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, symptoms clear up and return within a few days.

Frequently Asked Questions

What is Hemorrhoidal used for?

Hemorrhoidal contains mineral oil, petrolatum, phenylephrine HCl. It is a ointment taken rectal. Consult your doctor for specific uses.

Is Hemorrhoidal a controlled substance?

Hemorrhoidal is not classified as a controlled substance by the DEA.

What is the generic name for Hemorrhoidal?

The generic name for Hemorrhoidal is mineral oil, petrolatum, phenylephrine HCl. There are 10 other brand versions of mineral oil, petrolatum, phenylephrine HCl.

What is the NDC code for Hemorrhoidal 14 g/100g?

The NDC (National Drug Code) for Hemorrhoidal 14 g/100g is 63187-505, listed by Proficient Rx LP.

Product NDC

63187-505

Package NDC

63187-505-02

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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