Active ingredient A list of the active, medicinal ingredients in the drug product.
Active ingredient Miconazole nitrate 2%
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 affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product use daily for 2 weeks; If conditions persists, consult a doctor this product is not effective on the scalp or nails if nozzle clogs, clean with a pin
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredient disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch
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 jock itch (tinea cruris) relieves itching, burning and chafing associated with jock itch
Purpose Information about the drug product’s indications for use.
Spl product data elements Usually a list of ingredients in a drug product.
Miconazole Nitrate Jock Itch Spray DISTEARDIMONIUM HECTORITE ISOBUTANE KAOLIN ALCOHOL ZEA MAYS SUBSP. MAYS WHOLE MICONAZOLE NITRATE MICONAZOLE
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 equate Jock Itch Powder Spray Miconazole Nitrate 2% Antifungal Cures Most Jock Itch Talc-free Relieves itching, chafing and burning NET WT 4.6 OZ (130 g) jock itch
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 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 between 20 o C and 30 o C (68 o and 86 o F)
Questions A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
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 no improvement within 2 weeks
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 do not get into eyes or mouth use only as directed.
Safe handling warning Safe Handling Warning
Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal.
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. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by delibrately concentrating and inhaling contents can be harmful or fatal. When using this product do not get into eyes or mouth use only as directed. Stop use and ask a doctor if irritation occurs no improvement within 2 weeks Do not use on children under 2 years of age unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.