Panoxyl Cream
FDA Label NDC 0316-0227

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 0316-0227). 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 (4%), active ingredient (10%), purpose, use, warnings, do not use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (4%)

Benzoyl peroxide 4%

Active Ingredient (10%)

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 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
  • 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.

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

  • wet area to be cleansed
  • apply acne wash and gently massage area for 1-2 minutes
  • rinse thoroughly and pat dry
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 4%

carbomer homopolymer type C, carbomer interpolymer type A, decyl glucoside, dimethicone, dioctyl sodium sulfosuccinate, glycerin, palmitic acid, polyacrylate crosspolymer-6, polyoxyl 40 stearate, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium laurylglucosides hydroxypropylsulfonate, sorbitan stearate, sorbitol, stearic acid, t-butyl alcohol, xanthan gum

Inactive Ingredients 10%

carbomer homopolymer type C, carbomer interpolymer type A, decyl glucoside, dimethicone, dioctyl sodium sulfosuccinate, glycerin, palmitic acid, polyacrylate crosspolymer-6, polyoxyl 40 stearate, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium laurylglucosides hydroxypropylsulfonate, sorbitan stearate, stearic acid, t-butyl alcohol, xanthan gum

Questions Or Comments?

call 1-833-279-6522

Panoxyl is a registered trademark of Crown Laboratories, Inc.

©2018 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

TAMPER-EVIDENT FEATURE: For your protection, do not use if foil seal on tube is broken or missing.

Panoxyl 4% Carton

NDC 0316-0227-06

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE CREAMY WASH

Benzoyl Peroxide 4%

Daily Control

Daily Cleaning Wash

Face

Chest

Back

  • Clears existing acne blemishes and helps prevent new blemishes from forming
  • Formulated to be gentle on skin
  • Contains benzoyl peroxide, an antibacterial ingredient
  • Patent Pending Acne Control Formula

    • Net wt. 6 oz (170 g)

    P11533.00

Panoxyl 10% Carton

NDC 0316-0228-55

DERMATOLOGIST RECOMMENDED

PanOxyl ®

ACNE FOAMING WASH

Benzoyl Peroxide 10%

Maximum Strength

Deep Cleaning Wash

Face

Chest

Back

  • Clears existing acne blemishes and helps prevent new blemishes from forming
  • Formulated to be gentle on skin
  • Contains benzoyl peroxide, an antibacterial ingredient
  • Patent Pending Acne Control Formula

    • Net wt. 5.5 oz (156 g)

    P11537.00

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