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Clotrimazole - Prescription Drug Labeling

Product NDC Code 69396-038
Drug Name

Clotrimazole

Type Brand
Active Ingredients
Clotrimazole 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 309367
Application Number part333C
Labeler Name Trifecta Pharmaceuticals USA LLC
Packages
Package NDC Code Description
69396-038-05 1 tube in 1 box (69396-038-05) > 15 g in 1 tube

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, Glyceryl Stearate SE, Laureth-23, Light Mineral Oil, Petrolatum, Stearyl Alcohol, 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, burning, cracking, 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 Family Wellness Clotrimazole DIMETHYL SULFOXIDE ETHYLPARABEN GLYCERIN GLYCERYL STEARATE SE LAURETH-23 LIGHT MINERAL OIL PETROLATUM STEARYL ALCOHOL WATER 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.
Packaging family wellness clotrimazole 05oz

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 (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? Call 1-888-296-9067 Mon-Fri 9AM - 5PM DISTRIBUTED BY: MIDWOOD BRANDS, LLC. 500 Volvo Parkway, Chesapeake, VA. 23320 NOT SATISFIED? Return Package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange. This product is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®

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 or ringwork) or within 2 weeks (for jock itch).

Pregnancy or breast feeding

Pregnancy or Breast feeding
If Pregnant or breastfeeding If Pregnant or breastfeeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information store at controlled room temperature 20°-25°C (68°- 77°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 ● Do not use on children under 2 years of age except under the advice of a doctor. ● For external use only ● When using this product avoid contact with eyes.

Disclaimer: Do not rely on openFDA 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