1. Home
  2. Labeler Index
  3. Fourstar Group Usa, Inc.
  4. 80684-039
  5. Label Information: Thera Plus Antifungal Clotrimazole

FDA Label for Thera Plus Antifungal Clotrimazole

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. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE LABELING:

Thera Plus Antifungal Clotrimazole 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



Clotrimazole 1% w/w


Purpose



Antifungal


Uses



  • cures most athlete’s foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which can accompany these conditions.

Warnings



For external use only.


Do Not Use



  • on children under 2 years of age except under the advice of a doctor.

When Using This Product



  • avoid contact with eyes.

Stop Use And Ask A Doctor If



  • irritation occurs.
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch).

If Pregnant Or Breast-Feeding,



ask a health professional before use


Keep This And All Drugs Out Of The Reach Of Children.



if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



  • wash the 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 the spaces between the 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 conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other Information



  • store at room temperature 20°-25°C (68°-77°F).
  • close cap tightly after use.

Inactive Ingredients



cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid


Questions Or Comments?



Call 1-888-296-9067 Mon-Fri 9 AM-5 PM


* Please review the disclaimer below.