Drugplain

Pramoxine Hydrochloride Anorectal 1 mg/mL

Pramoxine Hydrochloride · LOTION · Stratus Pharmaceuticals

No Recall History
Plain English

Pramoxine Hydrochloride Anorectal is a lotion containing pramoxine hydrochloride at 1 mg/mL, taken topical. Manufactured by Stratus Pharmaceuticals.

Key Facts

Brand Name
Pramoxine Hydrochloride Anorectal
Generic Name
Pramoxine Hydrochloride
NDC Code (Product)
58980-522
Manufacturer
Stratus Pharmaceuticals
Strength
1 mg/mL
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M015
Marketing Start
11/01/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for the temporary relief of itching and discomfort in the perianal area.

Dosage & Administration

Directions Shake well before using. When practical, cleansethe affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Adults and children 12 years of age and older: apply to affected area up to five times daily. Children under 12 years of age, consult a Physician.

Warnings

Warnings for external use only. Do not exceed the recommended daily dosage unless directed by a Physician. Do not put this product into rectum by using fingers or any applicator. Stop use and ask a Physician if Condition worsens Symptoms do not improve in 7 days Allergic reactions develop to ingredients in this product Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away.

Frequently Asked Questions

What is Pramoxine Hydrochloride Anorectal used for?

Pramoxine Hydrochloride Anorectal contains Pramoxine Hydrochloride. It is a lotion taken topical. Consult your doctor for specific uses.

Is Pramoxine Hydrochloride Anorectal a controlled substance?

Pramoxine Hydrochloride Anorectal is not classified as a controlled substance by the DEA.

What is the generic name for Pramoxine Hydrochloride Anorectal?

The generic name for Pramoxine Hydrochloride Anorectal is Pramoxine Hydrochloride. There are 12 other brand versions of Pramoxine Hydrochloride.

What is the NDC code for Pramoxine Hydrochloride Anorectal 1 mg/mL?

The NDC (National Drug Code) for Pramoxine Hydrochloride Anorectal 1 mg/mL is 58980-522, listed by Stratus Pharmaceuticals.