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| Product NDC Code | 71582-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Anti fungal |
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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 | LIQUID | ||||
| RxCUI drug identifier | 309370 | ||||
| Application Number | M005 | ||||
| Labeler Name | Guangzhou Ertiantang Pharmaceutical Co.,Ltd | ||||
| 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 Clotrimazole 1%
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 affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients GLACIAL ACETIC ACID, GARLIC OIL, OSTHOL, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK，PHRYMA LEPTOSTACHYA WHOLE, PHELLODENDRON CHINENSE WHOLE
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 cure of athlete's foot (tinea pedis), jock itch (tinea cruris) and ring worm (tinea corporis). • For relief of itching, scaling, burning and discomfort that accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose Coltrimazole 1% Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Anti Fungal Coltrimazole CLOTRIMAZOLE CLOTRIMAZOLE ACETIC ACID GARLIC OIL OSTHOL SOPHORA FLAVESCENS ROOT PSEUDOLARIX AMABILIS BARK PHRYMA LEPTOSTACHYA WHOLE PHELLODENDRON CHINENSE WHOLE
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.Drug Facts image description
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.Storage Store in cool, dry place away from direct sunlight.
Distributed by: Bluebird Health Company 3856 Walnut Grove Avenue Rosemead, CA 91770-1655 Phone: (626)677-1558 Made in China
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 On children under 2 years of age unless directed by a doctor.
Instructions for use
Information about safe handling and use of the drug product.When Use This Product • Avoid contact with the eyes. • This product is not effective on the 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 If swallowed, get medical help or contact a Poison Control Center right away.
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 occurs or if there is no improvement within 4 weeks (for athlete’s foot). • If irritation occurs or if there is no improvement within 4 weeks (for jock itch). • If condition persists longer, consult 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.
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