Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredient Clotrimazole 1% w/w Purpose Antifungal
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 over affected area twice daily (morning and night) 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 cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid
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 can accompany these conditions.
Purpose Information about the drug product’s indications for use.
Spl product data elements Usually a list of ingredients in a drug product.
Thera plus Antifungal Clotrimazole CLOTRIMAZOLE LAURETH-23 CETOSTEARYL ALCOHOL ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE MINERAL OIL PETROLATUM WATER STEARIC ACID 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.
Package Labeling: Outer Package Inner Package
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.
Other information store at room temperature 20°-25°C (68°-77°F). close cap tightly after use.
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 except under the advice of 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. 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 9 AM-5 PM
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 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.
Pregnancy or breast feeding Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before 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. Do not use on children under 2 years of age except under the advice of a doctor. 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 or ringworm) or within 2 weeks (for jock itch). If pregnant or breast-feeding, ask a health professional before use 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.