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| Product NDC Code | 73503-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Acne therapy moisturizing |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 248609 | ||||
| Application Number | M006 | ||||
| Labeler Name | PSODEX USA 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 ingredient Salicylic Acid 1.5%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Acne is a common skin condition that can fluctuate over time. The main goal of treatment is to manage symptoms PSODEX Anti Acne Care Cream offers a soothing formula that helps block the recurrence of acne symptoms with the help of SALICYLIC ACID PREVENTS: Excessive sebum secretion RELIEVES: Itching, inflammation, and roughness CONTROLS: Flaking and scaling HELPS BLOCK: Recurrence of acne symptoms
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.Active ingredient Salicylic Acid 1.5%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Allantoin, Aloe Barbadensis Leaf Extract, Azelaic Acid, Benzoic Acid, a-Bisabolol, Cetyl Alcohol, Chloroxylenol, Dehydroacetic Acid, Di-C12-13 Alkyl Malate, Dipropylene Glycol, Distilled Water, Glyceryl Monostearate, Hydrogen Peroxide, Laureth-9, Mentha Piperita Extract, Octyldodecanol, Panthenol, Paraffinum Liquidum, Phenoxyethanol, Urea, Xanthan Gum, Zinc Oxide
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 Helps prevent new acne pimples from forming
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.Acne Therapy Moisturizing Salicylic Acid LEVOMENOL PHENOXYETHANOL ALOE VERA LEAF POLIDOCANOL OCTYLDODECANOL HYDROGEN PEROXIDE UREA MENTHA PIPERITA LEAF PANTHENOL MINERAL OIL DEHYDROACETIC ACID CHLOROXYLENOL ZINC OXIDE XANTHAN GUM ALLANTOIN CETYL ALCOHOL GLYCERYL MONOSTEARATE DIPROPYLENE GLYCOL BENZOIC ACID DI-C12-13 ALKYL MALATE AZELAIC ACID WATER SALICYLIC ACID SALICYLIC ACID
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.package
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.Ask a doctor before use if Condition covers a large area of the body
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 For prolonged periods of time without consulting a doctor On large or deep wounds On damaged or irritated skin not caused by acne On healthy skin In or around the rectum, genital area, or on the groin unless advised by a doctor
Information for owners or caregivers
Information for owners or caregiversDISTRIBUTED BY: Psodex USA Inc. 9898 Bissonnet St Ste 625 Houston, TX 77036 1-844 4PSODEX www.psodexusa.com MANUFACTURED FOR Yesim Derma Laboratories
Instructions for use
Information about safe handling and use of the drug product.Directions Cleanse the skin thoroughly before applying the product Apply to affected areas with a thin layer, one to three times daily or as directed by a doctor
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 1 844 4PSODEX | [email protected]
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 Excessive skin irritation/allergic reaction occurs, condition worsens or does not improve after regular use of this product as directed.
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 contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature 59-86°F
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
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