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| Product NDC Code | 67777-316 | ||||
|---|---|---|---|---|---|
| Drug Name | Dynarex antifungal powder |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER | ||||
| RxCUI drug identifier | 998461 | ||||
| Application Number | part333C | ||||
| Labeler Name | Dynarex Corporation | ||||
| 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 Active Ingredient Purpose Miconazol 2% Antifungal
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 Sprinkle onto the affected area twice daily. It can be safely applied to broken skin and may also be sprinkled onto clothes and footwear, which come into contact with the infected area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Colloidal silicon dioxide, talc.
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.Cautions Please read this label carefully before use. • Dynarex Antifungal Powder is not suitable for the treatment of fungal infections of the scalp or nails, and you should talk to your doctor or pharmacist for alternative treatments for these conditions. In order to ensure successful treatment, it is important to use the powder regularly and to continue for at least 10 days after the disappearance of symptoms. This prevents the infection from reoccurring. • Remember that most fungal infections are very infectious and can easily be passed on to other family members. In order to prevent this happening, it is important to ensure that anyone who has an infection avoids sharing clothes, towels, or shoes with other family members. After applying the powder, wash and dry your hands thoroughly. If your skin condition does not improve after one week’s use, please consult your doctor or pharmacist. • If you forget to apply the powder, do not apply the missed dose, but apply the next dose as usual and continue as normal. Do not apply two doses at the same time. Interactions If you are taking oral anticoagulants (drugs used to thin the blood, such as Warfarin), talk to your doctor or pharmacist before use. Overdose Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. In case of accidental ingestion of powder go to the hospital immediately.
Purpose
Information about the drug product’s indications for use.Purpose Uses For external treatment of fungal infections such as athlete’s foot, jock itch, sweat rash, infected diaper rash and fungal infections affecting the skin folds e.g. armpits, groin, or under the breasts.
Spl product data elements
Usually a list of ingredients in a drug product.Dynarex Antifungal Powder Miconazole SILICON DIOXIDE TALC 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 Dynarex Antifungal Powder 1236 AntiPowGP.jpg Antifungal Powder
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.Other information Keep the medicine in the original packaging in a dry place, at a temperature not exceeding 30ºC/86ºF. Protect from light. Do not use after the expiry date shown on the pack.
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 Do not use: ■ if you are sensitive to any of the active or inactive ingredients listed ■ if the infection is on your scalp or nails.
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 Keep Out Of Reach Of Children Do not let the powder get into your eyes. This product contains talc. Do not breathe in the powder as this may cause irritation of the airways. This is especially important for children and infants. If swallowed, contact a poison control center immediately.
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. Consult a doctor or pharmacist before using this product if you: ■ Are sensitive to the listed ingredients or any similar medications ■ Are pregnant, planning a pregnancy or breastfeeding When using this product: You may occasionally experience some side effects. These are rare and consist of local skin irritation or rashes, which occur if you are unusually sensitive to the ingredients listed.
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