Panoxyl Soap
FDA Label NDC 0316-0288

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 0316-0288). 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

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

  • wet face and work product into a lather
  • cover the entire affected area with a thin layer one to three times daily
  • rinse thoroughly and 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

Other Information

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

Inactive Ingredients

Aqua, Butyrospermum Parkii (Shea Butter), Cocamidopropyl Hydroxysultaine, Galactoarabinan, Glycerin, Mandelic Acid, Sodium Chloride, Sodium Cocoate*, Sodium Gluconate, Sodium Palm Kernelate*, Sodium Palmate, Tetrasodium EDTA, Tetrasodium Glutamate Diacetate, Titanium Dioxide (CI 77891), Zinc PCA *contains one or more of these ingredients

Questions?

call 1-833-279-6522

Panoxyl Acne Treatmet Bar Carton

PanOxyl

Acne Cleansing Bar

for Face & Body

2% SALICYLIC ACID

ACNE TREATMENT BAR

DAILY CONTROL

Clears and helps prevent acne

Gentle, hypoallergenic formula

Helps exfoliate for a clearer complexion

DERMATOLOGIST RECOMMENDED

Net wt. 4 oz (113 g)

Distributed by: Crown Laboratories, Inc.

Johnson City, TN 37604

panoxyl.com

P12961.00

* Please review the disclaimer below.