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| Product NDC Code | 71205-738 | ||||
|---|---|---|---|---|---|
| Drug Name | Rugby antifungal 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 | Proficient Rx LP | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient 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 • wash affected area and dry thoroughly • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor • supervise children in 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 • if condition persists longer, consult a doctor • this product is not effective on scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA
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, jock itch, and ringworm • relieves itching, burning, cracking, scaling and discomfort
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.RUGBY ANTIFUNGAL CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL DMDM HYDANTOIN GLYCERYL MONOSTEARATE ISOPROPYL ALCOHOL METHYLPARABEN MINERAL OIL POLYSORBATE 20 PROPYLPARABEN WATER STEARIC ACID TROLAMINE EDETATE TRISODIUM
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 - 14 g Tube Carton NDC 71205-738-15 Compare to the active ingredient of Lotrimin ® AF* Antifungal Cream Clotrimazole 1% Cures most athlete's foot NET WT 0.5 OZ (14 g) 71205-738-15
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: RUGBY ® LABORATORIES 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 Relabeled by: PROFICIENT RX LP Thousand Oaks, CA 91320
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.
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 (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-645-2158
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 and ringworm or 2 weeks for jock itch
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 15 to 30°C (59 to 86°F) • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
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 contact with eyes. Do not use on children under 2 years of age unless directed by a doctor. Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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