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| Product NDC Code | 50382-014 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tolnaftate |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 103951 | ||||||
| Application Number | M005 | ||||||
| Labeler Name | Galentic Pharma (India) Private Limited | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.• ACTIVE INGREDIENT 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 apply 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 for athlete's foot, pay special attention to 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 condition 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 INGREDIENT Ceteth 20, Cetyl alcohol, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Sorbitan Monostearate, Stearyl Alcohol, Purified 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 Proven clinically effective in the treatment of most athlete's foor (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) for effective relief of itching , burning and cracking
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.Tolnaftate Tolnaftate CETYL ALCOHOL CETETH-20 METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL SORBITAN MONOSTEARATE WATER MINERAL OIL STEARYL ALCOHOL TOLNAFTATE TOLNAFTATE
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 - 14 g Tube Carton Galentic Antifungal Cream For treatment of athlete's foot, jock itch, and ringworm Tolnaftate Cream NET WT. 1 OZ (28 g) principal display panel.jpg
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.Manufactured by: Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone, Gandhidham - 370230, Gujarat, India
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.Do not use on children 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 immediately.
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 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 store between 15° to 30°C (59° to 86°F) Lot No. & Exp. Date: See box or crimp of tube
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 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 2 weeks (for jock itch) Do not use on children 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 immediately.
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