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| Product NDC Code | 50066-052 | ||||
|---|---|---|---|---|---|
| Drug Name | Asepxia acne treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 106315 | ||||
| Application Number | M006 | ||||
| Labeler Name | Genomma Lab USA Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzoyl Peroxide 10%
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 ♦ 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 sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor Sensitivity test for new user ♦ apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer, disodium EDTA, hydroxypropyl methylcellulose, Laureth-4, 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 ♦ dries and clears acne blemishes ♦ penetrates pores to eliminate most acne blemishes ♦ helps prevent new acne blemishes
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.Asepxia Acne Treatment Benzoyl Peroxide Benzoyl Peroxide Benzoyl Peroxide CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE Edetate Disodium Hypromellose, Unspecified Laureth-4 Sodium Hydroxide Water
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 - 28 g Tube Carton Asepxia ® ACNE TREATMENT CREAM 10% BENZOYL PEROXIDE > ELIMINATES MOST PIMPLES AND BLACKHEADS NET WT./ CONT. NET. 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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
Distributed by: Genomma Lab USA Inc., Houston, TX 77027
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 ♦ if you 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? 1 877 994 3666. Monday to Friday, 8am to 6pm, Central time.
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 ♦ avoid unnecessary sun exposure and use a sunscreen ♦ avoid contact with eyes, lips and mouth ♦ avoid contact with hair and dyed fabrics, which may be bleached by this product ♦ skin irritation and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne medication at a time ♦ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using this product less frequently or at a lower concentration
Storage and handling
Information about safe storage and handling of the drug product.Other information ♦ Keep tightly closed ♦ Store at 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 ♦ if you are sensitive to benzoyl peroxide When using this product ♦ avoid unnecessary sun exposure and use a sunscreen ♦ avoid contact with eyes, lips and mouth ♦ avoid contact with hair and dyed fabrics, which may be bleached by this product ♦ skin irritation and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne medication at a time ♦ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using this product less frequently or at a lower concentration Stop use and ask a doctor if ♦ irritation becomes severe 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