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| Product NDC Code | 70000-0493 | ||||
|---|---|---|---|---|---|
| Drug Name | Athletes foot |
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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 | Cardinal Health 110,Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Clotrimazole USP 1% w/w
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 <This product is not effective on the scalp or nails. Clean the affected area and dry thoroughly. Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product. use daily for 2 weeks. If conditions persists longer, consult a doctor.>
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, 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.Uses Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and chafing associated with jock itch.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal Cream
Spl product data elements
Usually a list of ingredients in a drug product.Athletes Foot CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE WATER CETOSTEARYL ALCOHOL POLYSORBATE 60 BENZYL ALCOHOL SORBITAN MONOSTEARATE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF OCTYLDODECANOL CETYL PALMITATE
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 oz. Tube Leader NDC 70000-0493-1 CLOTRIMAZOLE 1% ANTI-FUNGAL CREAM Cures Most Athlete's Foot NET WT. 0.5oz ( 14.2 g) Compare to Lotramin Principal Display Panel – 0.5 oz. Tube
Principal Display Panel – 0.5 oz. Carton Leader NDC 70000-0493-1 Cures Most Athlete's Foot Relieves Itching, Burning, Scaling, Discomfort and Chafing CLOTRIMAZOLE 1% ANTI-FUNGAL CREAM *Compare To the active ingredient in Lotrimin-AF® NET WT. 0.5oz (14.2g) Principal Display Panel – 0.5 oz. 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
Other information Store at controlled room temperature 20°-25°C (68°-77°F). Close cap tightly after use.
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. For external use only. Avoid contact with eyes. Stop Use and ask a doctor if irritation occurs or if there is no improvement within two weeks.
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 this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? For Questions or comments or to report an undesired reaction or side effect, please call 1-800-222-1222
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 Do not use on children under 2 years of age unless directed by a doctor. For external use only. Avoid contact with eyes. Stop Use and ask a doctor if irritation occurs or if there is no improvement within two weeks. Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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