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| Product NDC Code | 0316-0227 | ||||
|---|---|---|---|---|---|
| Drug Name | Panoxyl |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M006 | ||||
| Labeler Name | Crown Laboratories | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl peroxide 4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients (4%) Aqua, Carbomer, Decyl Glucoside, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Glycerin, Oleic Acid, Palmitic Acid, PEG-40 Stearate, Polyacrylate Crosspolymer-6, Propanediol, Silica, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Stearate, Sorbitol, Stearic Acid, t-Butyl alcohol, Xanthan Gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use for the treatment of acne
Purpose
Information about the drug product’s indications for use.Purpose Acne medication
Spl product data elements
Usually a list of ingredients in a drug product.PanOxyl benzoyl peroxide XANTHAN GUM CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) DIMETHICONE DOCUSATE SODIUM PALMITIC ACID SODIUM CITRATE SODIUM CHLORIDE TERT-BUTYL ALCOHOL SORBITAN MONOSTEARATE SILICON DIOXIDE WATER AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) SORBITOL GLYCERIN DECYL GLUCOSIDE STEARIC ACID CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM HYDROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE POLYOXYL 40 STEARATE PROPANEDIOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Panoxyl 4% Tube NDC 0316-0227-06 DERMATOLOGIST RECOMMENDED PanOxyl® ACNE CREAMY WASH 4% Benzoyl Peroxide Daily Control Clears Existing Acne and Helps Prevent New Breakouts from Forming Treats Acne on Face and Body Formulated to be Gentle on Skin Net wt. 6oz (170g) TAMPER-EVIDENT FEATURE: For your protection, do not use if foil seal on tube is broken or missing. P11532.03 PANOXYL is a registered trademark of Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 PanOxyl 4% Tube
Panoxyl 4% Carton NDC 0316-0227-06 DERMATOLOGIST RECOMMENDED PanOxyl® ACNE CREAMY WASH 4% Benzoyl Peroxide Daily Control Clears Existing Acne and Helps Prevent New Breakouts from Forming Treats Acne on Face and Body Formulated to be Gentle on Skin Net wt. 6oz (170g) PANOXYL is a registered trademark of Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 P11730.02 PanOxyl 4% Carton
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have very sensitive skin are sensitive to benzoyl peroxide
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call 1-833-279-6522
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if irritation becomes severe
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API