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| Product NDC Code | 11523-0138 | ||||
|---|---|---|---|---|---|
| Drug Name | Tinactin jock itch |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, POWDER | ||||
| RxCUI drug identifier | 705934, 705936 |
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| Application Number | M005 | ||||
| Labeler Name | Bayer HealthCare LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (To Deliver) Tolnaftate 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 affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks; if condition persists longer, ask 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 butylated hydroxytoluene, hydroxypropyl cellulose, isobutane, kaolin, magnesium stearate, PPG-12-buteth-16, SD alcohol 40-B (9% w/w), 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 for effective relief of itching, chafing and burning
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.Tinactin Jock Itch Tolnaftate BUTYLATED HYDROXYTOLUENE ISOBUTANE PPG-12-BUTETH-16 KAOLIN TOLNAFTATE TOLNAFTATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED STARCH, CORN white to off-white
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 - 133g Can Label TOUGH ACTIN' ® Tinactin ® tolnaftate ANTIFUNGAL Cures Most Jock Itch Relieves: Itching Burning POWDER SPRAY Goes On Dry Talc Free NET WT 133g (4.6 oz) PDP
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
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.For external use only Flammable: Do not use near heat, flame, or while smoking
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-360-3266 or visit us at www.tinactin.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 a doctor if irritation occurs there is 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 avoid contact with the eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° to 25°C (68° to 77°F)
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 near heat, flame, or while smoking Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks 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