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| Product NDC Code | 49348-279 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunmark clotrimazole |
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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 | CREAM | ||||
| RxCUI drug identifier | 309367 | ||||
| Application Number | M005 | ||||
| Labeler Name | Strategic Sourcing Services LLC | ||||
| 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 Clotrimazole USP, 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 for best results, follow directions and continue treatment for length of time indicated to open, use pointed end on cap to puncture seal clean skin with soap and water and dry thoroughly apply a thin layer over affected area morning and evening 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 best results in athlete's foot and ringworm are usually obtained with 4 weeks use, and in jock itch, with 2 weeks use. If satisfactory results have not occurred within these times, ask a doctor or pharmacist. children under 12 years of age should be supervised in the use of this product this product is not effective on the scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
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 cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) effectively relieves itching, cracking, burning and discomfort which can accompany these conditions
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.SUNMARK CLOTRIMAZOLE Clotrimazole BENZYL ALCOHOL CETOSTEARYL ALCOHOL CETYL ESTERS WAX OCTYLDODECANOL POLYSORBATE 60 WATER SORBITAN MONOSTEARATE CLOTRIMAZOLE CLOTRIMAZOLE
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 - 30 g Tube Carton sunmark ™ antifungal cream Clotrimazole Cream USP, 1% CURES MOST ATHLETE'S FOOT NET WT 1 OZ (30 g) PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
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.Drug Facts
Distributed by McKesson One Post Street San Francisco, CA 94104
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 except under the advice and supervision of 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.
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 there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
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 use only as directed avoid contact with the eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 2°-30°C (36°-86°F) do not use if seal on tube is broken or is not visible See box or tube crimp for lot number and expiration date.
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 use only as directed avoid contact with the eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch) Do not use on children under 2 years of age except under the advice and supervision of a doctor. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
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