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  5. Label Information: Thera Plus Antifungal Tolnaftate

FDA Label for Thera Plus Antifungal Tolnaftate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABELING:

Thera Plus Antifungal Tolnaftate Product Label

The following document was submitted to the FDA by the labeler of this product Fourstar Group Usa, Inc.. 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 Ingredient



Tolnaftate 1%


Purpose



Anti-Fungal


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 immediately.


Directions



  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete’s foot: pay special attention to spaces between the toes, wear well-ftting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks ; if condition persists longer, ask a doctor.
  • to prevent athlete’s foot, apply once or twice daily (morning and/or night).
  • this product is not effective on the scalp or nails.

Other Information



  • store at room temperature 20° to 25°C (68° to 77°F)
  • lot no & expiration date: see box or crimp of tube

Inactive Ingredients



cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate


Questions?



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