Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 69882-726 | ||||
|---|---|---|---|---|---|
| Drug Name | Signature black bottle tea tree antifungal foot and body wash |
||||
| Type | Brand | ||||
| Active Ingredients |
|
||||
| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 283693 | ||||
| Application Number | M005 | ||||
| Labeler Name | Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) | ||||
| Packages |
|
||||
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients: Tolnaftate 1.0% Purpose: Antifungal
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 the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily Use daily for 4 weeks; if condition persists longer, ask a doctor Prevent athlete's foot, apply once or twice daily (morning and/or night 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: Acrylates copolymer, aqua (deionized water), cocamide MEA, cocamidopropyl betaine, disodium oleamido MEA sulfosuccinate, dl-panthenol, DMDM hydantoin, glycol stearate, isopropyl myristate, melaleuca alternifolia (australian tea tree) leaf oil, mentha piperita (peppermint) oil, origanum vulgare (oregano) leaf oil, sodium laureth sulfate, sodium lauryl sulfate, triethanolamine.
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.Signature Black Bottle Tea Tree Antifungal Foot and Body Wash TOLNAFTATE WATER COCO MONOETHANOLAMIDE COCAMIDOPROPYL BETAINE DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE PANTHENOL DMDM HYDANTOIN GLYCOL STEARATE ISOPROPYL MYRISTATE TEA TREE OIL PEPPERMINT OIL OREGANO LEAF OIL SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE TROLAMINE 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.Package Labeling: Label
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
Other information Store between 20° to 25°C (68° to 77°F)
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 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
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
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 Do not use on children under 2 years of age except under the advice and supervision of a doctor 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 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