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  5. Label Information: Major Clotrimazole

FDA Label for Major Clotrimazole

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. HOW SUPPLIED

Major Clotrimazole Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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.

Other



Drug Facts


Active Ingredient



Clotrimazole USP 1% w/w


Purpose



Antifungal Cream


Uses



Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.


Otc - Do Not Use



  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children



  • Keep this and all drugs out of the reach of children.

    • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Directions



  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product 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.
  • 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 controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.

Inactive Ingredients



aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water


Questions?



Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Oder No. 100431


How Supplied



Product: 50090-0524

NDC: 50090-0524-0 14.17 g in a TUBE / 1 in a CARTON


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