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Clotrimazole - Medication Information

Product NDC Code 63187-501
Drug Name

Clotrimazole

Type Generic
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Clotrimazole 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 309367
Application Number M005
Labeler Name Proficient Rx LP
Packages
Package NDC Code Description
63187-501-15 1 tube in 1 carton (63187-501-15) / 15 g in 1 tube
63187-501-30 1 tube in 1 carton (63187-501-30) / 30 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 This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. • clean 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; change shoes and socks at least once daily

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) • for effective relief of • itching • scaling • cracking • burning • redness • soreness • irritation • 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.
Clotrimazole Clotrimazole Clotrimazole Clotrimazole benzyl alcohol cetostearyl alcohol cetyl esters wax polysorbate 60 water sorbitan monostearate Smooth

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 - 15 g Carton Cures Most Athlete's Foot Athlete's Foot Cream Clotrimazole Cream USP,1% Antifungal Cream Antifungal Cream NET WT (1/2 oz) 15 g 63187-501-15

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: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use • on children under 2 years of age

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 1-866-923-4914

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 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 eyes

Storage and handling

Information about safe storage and handling of the drug product.
Other information • To open: unscrew cap, use the pointed end of cap to puncture seal. • store between 2°- 30°C (36° - 86°F) • see carton 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 Ask a doctor before use • on children under 2 years of age When using this product • avoid contact with eyes Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch) 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