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| Product NDC Code | 69396-001 | ||||||||||||
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| Drug Name | Clotrimazole |
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| Type | Generic | ||||||||||||
| 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 | TRIFECTA PHARMACEUTICALS USA LLC | ||||||||||||
| 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 Wash 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. ● For athlete’s foot, pay special attention to the 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 conditions persists longer, consult a doctor. ● 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 Dimethyl Sulfoxide, Ethylparaben, Glycerin, Laureth-23, Mineral Oil, Petrolatum, Water, alcohol, Glyceryl mono and dipalmitostearate, Cetostearyl alcohol, edetate disodium, Butylated Hydroxytoluene.
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 discomfort which can accompany these conditions.
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.Clotrimazole Clotrimazole MINERAL OIL DIMETHYL SULFOXIDE ETHYLPARABEN GLYCERIN LAURETH-23 PETROLATUM WATER EDETATE DISODIUM CLOTRIMAZOLE CLOTRIMAZOLE GLYCERYL MONO AND DIPALMITOSTEARATE BUTYLATED HYDROXYTOLUENE ALCOHOL CETOSTEARYL ALCOHOL
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.4010 GLOBE CLOTRIMAZOLE CREAM 1OZ LONG HANGING REV06 011023 CDER
4315 GLOBE CLOTRIMAZOLE CREAM 4OZ 081523 CDER
4020-FBA-1 GLOBE CLOTRIMAZOLE CREAM 1OZ 5PK BOX 101323 CDER
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 on children under 2 years of age unless direcgted 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 this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Keep this and all drugs out of the reach of children In case of accidental ingestion, seek professional assistance or contact Poison Control Centre 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? Adverse drug event call 1-888-296-9067 Dist. By Trifecta Pharmaceuticals USA® 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL 33301, USA
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 doctor if irritaion occurs There is no improvement within 4 weeks (for athlete's foot or ringworm) or within 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 When using this product avoid contact with eyes
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at controlled room temperature 15°-30°C (59°- 86°F) Close cap tightly after use.
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