Otc - Active Ingredient
Tolnaftate 1%
Probliva Antifungal Scrub .soap. Bar Soap
FDA Label NDC 85464-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cavtech Holding Llc for the product Probliva Antifungal Scrub .soap. Bar (NDC 85464-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - keep out of reach of children, indications & usage, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Dosage & Administration
- For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jock itch(tinea cruris)
- For effective relief of itching, burning and cracking skin.
Warnings
For external use only
When using this product
Avoid contact with the eyes. Ifcontact occurs, rinse thoroughly with water.
Stop and ask a doctor if
- Irritation occurs or if there is noimprovement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm
- Excessive irritation occurs.
- on broken, irritated, or severely damaged skin
- on children under 2 of age except under the advice and supervision of a doctor.
Do not use
Otc - Keep Out Of Reach Of Children
If swallowed, get medical helpor contact a Poison Control Center right away.
Indications & Usage
- Wash affected area well and let product sit 2-3minutes before rinsing
- Make sure to dry affected area thoroughly
- Supervise children in the use of this product
- For Athlete's foot: pay special attention to the spacesbetween the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
- Use 1-2 times daily. Use daily for 4 weeks; if the condition persists longer, aska doctor
- This product is not effective on the scalp or nails.
Other Safety Information
- Store at room temperature 59°- 86°F(15°-30°C)
- Keep the bar dry between uses
Inactive Ingredient
Water, Cocos Nucifera (Coconut) Oil, Melaleuca Alternifolia(Tea Tree) Leaf Oil, Eucalyptus Oil, Walnut Shell Powder,Charcoal Powder, Propylene Glycol, Glycerin, Lauric Acid,Myristic Acid, Sorbitol, Elaeis Guineensis (Palm) Oil, Stearic Acid, Sodium Laureth Sulfate, Sucrose, Sodium Lauryl Sulfate,Soap Base (Sekken Soji, Sekken-Na/K), Bamboo Charcoal, Olea Europaea (Olive) Oil, Pumice, Butyrospermum Parkii (SheaButter), Neem Oil
Otc - Questions
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