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| Product NDC Code | 69070-305 | ||||
|---|---|---|---|---|---|
| Drug Name | Skinheal 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 | Zhejiang Dingtai Pharmaceutical Co., Ltd | ||||
| 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 1.0%
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 Adults and children 2 years of age or older: wash the affected area and dry thoroughly apply a thin layer of the product over the 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 change shoes and socks at least once daily use daily for 4 weeks for the treatment of athlete’s foot and ringworm if condition persists longer, consult a doctor use daily for the prevention of athlete’s foot this product is not effective on the scalp or nails Children under 2 years: do not use unless directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetostearyl alcohol, glycerin, glyceryl monostearate, petrolatum, propylene glycol, sodium sulfite, steareth- 20, stearic acid, and 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 foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete’s foot with daily use 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.SKINHEAL ANTIFUNGAL Tolnaftate TOLNAFTATE TOLNAFTATE CETOSTEARYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE PETROLATUM PROPYLENE GLYCOL SODIUM SULFITE STEARETH-20 STEARIC ACID WATER
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.SKINHEAL ANTIFUNGAL CREAM Tolnaftate 1% Net Wt. 10 g (1/3 oz) NDC 69070-305-01 Box2.jpg
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.
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? (888) 221-3496 M-F 9am-5pm you may also report serious side effects to this phone number
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
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 keep container tightly closed store between 15 and 30 C (59 to 86 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
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