Panoxyl Acne Banishing Body (spray) Aerosol, Spray
FDA Label NDC 0316-0297

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, Inc. for the product Panoxyl Acne Banishing Body (spray) (NDC 0316-0297). 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, when using this product, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Medication

Use

  • for the treatment of acne

Warnings

For external use only

Avoid spraying in eyes

Flammable: Keep away from fire or flame

Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

When Using This Product

  • 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.

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
  • cover the entire affected area with a thin layer one to three times daily
  • 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

Other Information

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

Inactive Ingredients

Alcohol Denat., Aloe Barbadensis Leaf Extract, Aqua, Benzoic Acid, Benzyl Alcohol, Dipropylene Glycol, Gluconolactone, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Propylene Glycol, Sodium Ascorbyl Phosphate, Sorbic Acid

Questions?

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