Panoxyl Soap
FDA Label NDC 0316-0264

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Crown Laboratories for the product Panoxyl (NDC 0316-0264). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use if you, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

  • for the treatment of acne

Warnings

For external use only

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When Using This Product

  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product

Stop Use And Ask A Doctor If

  • irritation becomes severe

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.

Directions

  • clean the skin thoroughly before applying this product
  • work into a lather
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
  • pat dry
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

  • Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive Ingredients

Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate
Diacetate

Questions?

call 1-833-279-6522

Panoxyl Acne Treatmet Bar Carton

new

NDC 0316-0264-04

DERMATOLOGIST RECOMMENDED

PanOxyl ®

ACNE TREATMENT BAR

10% Benzoyl Peroxide

  • Deep Cleaning Face and Body Bar
  • Clears Existing Acne and Helps Prevent New Breakouts from Forming
  • Maximum Strength without a Prescription

    • Net wt. 4 oz (113 g)

* Please review the disclaimer below.