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  5. Label Information: Clotrimazole

FDA Label for Clotrimazole

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 10 ML BOTTLE CARTON

Clotrimazole Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma 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.

Other



Drug Facts


Active Ingredient



Clotrimazole USP, 1%


Purpose



Antifungal


Uses



Cures most

  • Athlete's foot (tinea pedis)
  • Jock Itch (tinea cruris)
  • Ringworm (tinea corporis)

    • Effectively relieves

    • Itching
    • Cracking
    • Burning

      • Discomfort which can accompany these conditions


Warnings



For external use only


Ask A Doctor Before Use



on children under 2 years of age


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 and ringworm) or 2 weeks (for jock itch)

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
  • clean the affected area and dry thoroughly
  • apply a thin layer of the 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 spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily


Other Information



  • Store at 15° to 30°C (59° to 86°F)

Inactive Ingredient



polyethylene glycol 400


Questions?



Please Call 1-877-225-6999


Principal Display Panel - 10 Ml Bottle Carton



NDC 71399-0500-1

Compare to the active ingredient of Lotrimin®AF*

Clotrimazole Topical Solution USP,1%

Antifungal

  • Relieves Itching & Burning
  • Greaseless, Nonstaining

    • For External use only.
    Not for Opthalmic use.

    Keep this and all medications out of the reach of children.

    Akron Pharma

    10ml

    Label - 1

    Label - 1

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* Please review the disclaimer below.