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| Product NDC Code | 49348-155 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunmark antifungal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 103951 | ||||
| Application Number | part333C | ||||
| Labeler Name | Strategic Sourcing Services 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 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) supervise children in the use of this product this product is not effective on scalp or nails For athlete's foot pay special attention to spaces between toes wear well-fitting shoes, 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum
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 clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) helps prevent most athlete's foot from recurring when used daily effectively soothes and relieves symptoms of athlete's foot, including 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.sunmark antifungal Tolnaftate Tolnaftate Tolnaftate Butylated Hydroxytoluene Polyethylene Glycol 400 Polyethylene Glycol 3350 titanium dioxide petrolatum
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 - 15 g Tube Carton sunmark ™ antifungal cream Tolnaftate 1% CURES & PREVENTS MOST ATHLETE'S FOOT NET WT 0.5 OZ (15 g) PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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
Distributed by McKesson One Post Street San Francisco, CA 94104
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
Do not use on children under 2 years of age except under the advice and supervision 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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 the eyes
Storage and handling
Information about safe storage and handling of the drug product.Other information Store between 15° - 30°C (59° - 86°F) See end panel of carton and tube crimp for lot number and expiration date
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 the 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) Do not use on children under 2 years of age except under the advice and supervision of a doctor. 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