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Clotrimazole - Medication Information

Product NDC Code 80489-002
Drug Name

Clotrimazole

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Clotrimazole 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 309367
Application Number part333C
Labeler Name OL PHARMA TECH,LLC
Packages
Package NDC Code Description
80489-002-01 1 tube in 1 carton (80489-002-01) / 28.3 g in 1 tube
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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 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 if condition lasts longer, contact 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 sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, 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 most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which 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.
Clotrimazole Drs. Clotrimazole CETOSTEARYL ALCOHOL PROPYLENE GLYCOL EDETATE DISODIUM CETEARETH-12 METHYLPARABEN STEARIC ACID .ALPHA.-TOCOPHEROL MINERAL OIL SODIUM CETOSTEARYL SULFATE TROLAMINE WATER PROPYLPARABEN 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.
original strenghth Antifungal cream clotrimazole

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 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 right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store at controlled room temperature 59°-86°F (15°-30°C). before using any medication, read all label directions. Keep carton, it contains important information

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
For Questions: www.drspharmacyusa.com

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 your doctor if: irritation occurs there is no improvement within 4 weeks (for athlete's foot and 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 avoid contact with the eyes

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