Miratiful Nail Fungus Treatment Solution
FDA Label NDC 87885-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Texas Miratiful Enterprises Inc. for the product Miratiful Nail Fungus Treatment (NDC 87885-001). 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 active ingredient             purpose, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient             Purpose


Tolnaftate 1%                Antifungal

Uses

  • Effective treatment of athlete’s foot, jock itch, and ringworm.
  • Not for the relief of infected fingernails and toenails or effective against bacteria or viruses.

Warnings

▪ For external use only.
▪ Avoid contact with the eyes.
▪ Do not use on children under 2 years of age unless directed by a doctor.
▪ Keep this and all drugs out of the reach of children.
▪ If treating athlete’s foot and ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
▪ If treating jock itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
▪ If swallowed, get medical help or contact a Poison Control Center right away.

Directions

▪ Clean or 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 athelete’s foot: Pay special attention to spaces between 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 Ingredients

Prunus amygdalus dulcis (Sweet almond) oil, Cymbopogan nardus (Citronella) oil, Lavandula augustifolia (Lavender) oil, Melaleuca alternifolia (Tea tree) oil, Simmondsia chinensis (Jojoba) oil, Syzyglum aromaticum (Clovebud) oil, Azadirachta indica (Neem) oil, Tocopheryl acetate (Vitamin E)

Product Label

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