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| Product NDC Code | 59958-401 | ||||
|---|---|---|---|---|---|
| Drug Name | Slmd spot treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 486131 | ||||
| Application Number | part333D | ||||
| Labeler Name | Owen Biosciences, Inc. | ||||
| 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 Ingredients 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.topical cleanser
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua) Propanediol Glycerin Neopentyl Glycol Diethylhexanoate Dimethicone Cyclopentasiloxane Cyclohexasiloxane Titanium Dioxide C12-15 Alkyl Benzoate Stearic Acid Behenoxy Dimethicone Behenyl Alcohol Glyceryl Stearate PEG-100 Stearate Myristoyl Tetrapeptide-13 Acetyl Carboxymethyl Cocoyl Glycine Panthenol Tocopheryl Acetate Sodium Hyaluronate Allatoin Glyceryl Oleate Behenic Acid Steareth-21 Steareth-2 Silica Carbomer Acrylates/C10-30 Alkyl Acrylate Crosspolymer Phenoxyethanol Ethylhexylglycerin Fragrance Tromethamine Alumina Polyhydroxystearic Acid
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 management of acne
Purpose
Information about the drug product’s indications for use.acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.SLMD Spot Treatment Benzoyl Peroxide WATER PROPANEDIOL GLYCERIN NEOPENTYL GLYCOL DIETHYLHEXANOATE BENZOYL PEROXIDE BENZOYL PEROXIDE
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.Acne Spot Treatment Back.jpg image description
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop us and ask a doctor if irritation becomes severe
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 have very senstive 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.
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.Directions Clean the skin thoroughly before applying 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 to three times daily if needed or as directed by a doctor.
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 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 this product less frequently or in a lower concentration
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