1. Home
  2. Labeler Index
  3. Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle)
  4. 69882-726
  5. Label Information: Signature Black Bottle Tea Tree Antifungal Foot And Body Wash

FDA Label for Signature Black Bottle Tea Tree Antifungal Foot And Body Wash

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF:
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS:
    11. OTHER INFORMATION
    12. PACKAGE LABELING:

Signature Black Bottle Tea Tree Antifungal Foot And Body Wash Product Label

The following document was submitted to the FDA by the labeler of this product Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle). The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.