Active Ingredient
Benzoyl Peroxide 10%
Panoxyl Acne Clearing Spot Treatment Gel
FDA Label NDC 0316-0298
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 Acne Clearing Spot Treatment (NDC 0316-0298). 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
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
- irritaiton becomes severe
If Pregnant Or Breast-Feeding,
ask a healthcare 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
- if going outside, apply a sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
- store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not exceed 30°C (86°F).
Inactive Ingedients
1,2-Hexanediol, 4-t-Butylcyclohexanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Bisabolol, Butyrospermum Parkii (Shea) Butter, Carbomer, Carbomer Homopolymer Type C, Citric Acid, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Isostearyl Alcohol, Niacinamide, PEG-40 Stearate, Pentylene Glycol, Propanediol, Silica, Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Stearate, Xanthan Gum
Questions?
call 1-833-279-6522
Panoxyl Acne Clearing Spot Treatment 1Oz Tube Pdp
PanOxyl
Acne Clearing Spot Treatment
for Face
10% BENZOYL PEROXIDE ACNE TREATMENT GEL
MAXIMUM STRENGTH
Clears existing ance and helps prevent new breakouts
DERMATOLOGIST RECOMMNENDED
Net wt. 1 oz (28 g)
Distributed by Crown Laboratories, Inc. Johnson City, TN
P12714.00
Panoxyl Acne Clearing Spot Treatment 1Oz Carton
PanOxyl
Acne Clearing Spot Treatment
for Face
10% BENZOYL PEROXIDE ACNE TREATMENT GEL
MAXIMUM STRENGTH
Clears existing ance and helps prevent new breakouts
Powerful, fast-acting maximum strength formula
No. 1 DERMATOLOGIST RECOMMNENDED BENZOYL PEROXIDE BRAND
Net wt. 1 oz (28 g)
Distributed by Crown Laboratories, Inc. Johnson City, TN
P12715.01
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