Signature Black Bottle Tea Tree Antifungal Foot And Body Wash Lotion
FDA Label NDC 69882-726

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle) for the product Signature Black Bottle Tea Tree Antifungal Foot And Body Wash (NDC 69882-726). 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 ingredients:, purpose:, uses, warnings, do not use, when using this product, stop use and ask a doctor if:, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Tolnaftate 1.0%

Purpose:

Antifungal

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

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.

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 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.

Other Information

Store between 20° to 25°C (68° to 77°F)

Package Labeling:

Label (Label)

Label (Label)

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