Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 58400-009 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Benzoyl peroxide cleanser |
||||||
| Type | Brand | ||||||
| Active Ingredients |
|
||||||
| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 1051006 | ||||||
| Application Number | M006 | ||||||
| Labeler Name | Pharmco Laboratories Inc. | ||||||
| Packages |
|
||||||
| 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 3.5%
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 Use once or twice daily. Morning and/or night. Apply to damp skin and Wash-In for up to 1 minute. Do not get in the eyes. For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion. Rinse off with warm water and pat dry with soft towel. If going outside, apply broad spectrum sunscreen SPF 15 or higher.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, FD&C Yellow # 5, Glycerine, Panthenol, Perlite, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide, Water
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.Uses For the treatment of acne.
Purpose
Information about the drug product’s indications for use.Purpose Acne Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Benzoyl Peroxide Cleanser Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide Water SODIUM C12-14 OLEFIN SULFONATE Disodium Cocoamphodiacetate Glycerin Propylene Glycol PERLITE Allantoin Panthenol Hyaluronate Sodium CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) Edetate Disodium Phenoxyethanol Ethylhexylglycerin Sodium Hydroxide FD&C Yellow NO. 5
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.PRINCIPAL DISPLAY PANEL - 170 g Bottle Label PHARMCO SKINCARE LABS Benzoyl Peroxide Cleansing Gel 3.5% Net wt. 6 oz. (170 g) PRINCIPAL DISPLAY PANEL - 170 g Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Manufactured by: Pharmco Laboratories Inc. • Titusville, FL 32780
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 call a poison control center immediately
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.If sensitivity develops or irritation becomes severe, stop use and ask a doctor.
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. If going outside, apply sunscreen after using this product.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.
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. If going outside, apply sunscreen after using this product. If sensitivity develops or irritation becomes severe, stop use and ask a doctor. Keep out of reach of children If swallowed get medical help or call a poison control center immediately Keep away from excessive heat or heat sources
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