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Product NDC Code | 84048-004 | ||||
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Drug Name | Antifungal cream |
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Type | Generic | ||||
Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 998483 | ||||
Application Number | M005 | ||||
Labeler Name | Shenzhen Peruidaishi Technology Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Miconazole nitrate 2%
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 1. First test a smallpatch of skin to checkfor any potentialallergic reaction. 2. Apply topically 2-3times daily to the affected area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Stemona Euphorbia Dictamnus Sophora Flavescens Aloe Cnidium Chlorhexidine acetate Vitamin E Borneol Natural menthol Stearic acid Medical vaseline Light liquid paraffin Glycerin Triethanolamine Purified 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.Use The product with Repairand Anti-ltch functioneffectively relieve skindiscomfort, such asitching, athlete's footeczema, jock itch, etc.
Purpose
Information about the drug product’s indications for use.Purpose Recuren Plus AntifungalCream, is equipped withreparative and anti-itchcapabilities.
Spl product data elements
Usually a list of ingredients in a drug product.Antifungal Cream Antifungal Cream EUPHORBIA NERIIFOLIA LEAF STEARIC ACID VASICINONE LIGHT MINERAL OIL TROLAMINE SOPHORA FLAVESCENS ROOT CHLORHEXIDINE ACETATE GLYCERIN STEMONA JAPONICA ROOT DICTAMNUS DASYCARPUS ROOT ALPHA-TOCOPHEROL BORNEOL ALOE MENTHOL WATER CNIDIUM MONNIERI FRUIT MICONAZOLE NITRATE MICONAZOLE
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 1
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 Oot Of Reach Of Children Keep Oot Of Reach Of Children
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 Stop use if there is no improvement within 4 weeks.
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 1. First test a smallpatch of skin to checkfor any potentialallergic reaction. 2. Apply topically 2-3times daily to theaffected area.
Storage and handling
Information about safe storage and handling of the drug product.Other information Keep it away from children. Seal the bottle and place it in a cool and dry place.
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.Avoid direct contactwith eyes.If irritation occurs,discontinue use.Keep out of reach ofchildren.Store in a cool, darkplace.
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