PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES

PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES is an FDA-registered drug product whose active ingredient is WITCH HAZEL. It is labelled by Haleon US Holdings LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0573-0553, application M015, label effective 20260511. It is one of 22 FDA drug label records sharing the active ingredient WITCH HAZEL. 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 WITCH HAZEL are most often described in connection with: helps relieve, local itching, discomfort associated, hemorrhoids temporary, relief irritation, burning aids, protecting irritated, anorectal areas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas

Directions adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area. use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard children under 12 years of age: consult a doctor

Warnings For external use only When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 22 drug label records with WITCH HAZEL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES used for?
Uses helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas

Who makes PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES?
Haleon US Holdings LLC is the labeler of record for PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES. 22 FDA label records share the active ingredient WITCH HAZEL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 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 PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES 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.

Are there other products containing WITCH HAZEL?
Yes. 22 FDA drug label records list WITCH HAZEL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPES been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.