FDA Label for Panoxyl

View Indications, Usage & Precautions

Panoxyl Product Label

The following document was submitted to the FDA by the labeler of this product Crown Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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



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


Questions Or Comments?



call 1-833-279-6522


Panoxyl 10% Carton



NDC 0316-0228-55

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE FOAMING WASH

10% Benzoyl Peroxide

Acne Treatment Wash

Maximum Strength

Clears Existing Acne and Helps Prevent New Breakouts from Forming

Treats Acne on Face and Body

Maximum Strength without a Prescription

Net wt. 5.5oz (156g)

PANOXYL is a registered trademark of Crown Laboratories, Inc.

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

P11731.04


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