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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. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    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 Rugby Laboratories, 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

Distributed by:
RUGBY ®LABORATORIES
Indianapolis, IN 46268


Active Ingredient



Clotrimazole USP, 1%


Purpose



Antifungal


Uses



  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and 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)

Otc - Keep Out Of Reach Of Children



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 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Inactive Ingredients



polyethylene glycol 400


Questions?



Call 1-866-923-4914


Principal Display Panel - 10 Ml Bottle Carton



Rugby ®

NDC 0536-1443-70
Compare to the
active ingredient in
Lotrimin ®AF*
Clotrimazole Antifungal

Clotrimazole
Topical Solution
USP, 1%
Antifungal

Cures Most
Athlete's Foot

* Please review the disclaimer below.