SIMPLE PROMISE Simple H Hemorrhoid Relief Cream

SIMPLE PROMISE Simple H Hemorrhoid Relief Cream is an FDA-registered drug product whose active ingredient is PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE. It is labelled by SIMPLE PROMISE PTE LTD taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 83311-335, application M015, label effective 20231106. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE are most often described in connection with: temporary relief, pain soreness, burning helps, local itching, discomfort associated, hemorrhoids temporarily, shrinks hemorrhoid, provides coating. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Directions • : 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 externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement Children under 12 years of age: ask a doctor. Adults

Warnings For external use only Do not use this product if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor. 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. • attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE: In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if • condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms 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.

What is SIMPLE PROMISE Simple H Hemorrhoid Relief Cream used for?
Uses • for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Who makes SIMPLE PROMISE Simple H Hemorrhoid Relief Cream?
SIMPLE PROMISE PTE LTD is the labeler of record for SIMPLE PROMISE Simple H Hemorrhoid Relief Cream.

What form does SIMPLE PROMISE Simple H Hemorrhoid Relief Cream come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is SIMPLE PROMISE Simple H Hemorrhoid Relief Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has SIMPLE PROMISE Simple H Hemorrhoid Relief Cream been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.