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  5. Label Information: Clotrimazole Cream, 1%

FDA Label for Clotrimazole Cream, 1%

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Clotrimazole Cream, 1% Product Label

The following document was submitted to the FDA by the labeler of this product Pharmaceutica North America, 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 USP 1%


Purpose



Antifungal


Uses



Cures athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.


Warnings



  • For external use only. 
  • Do not useon children under 2 years of age unless directed by a doctor. 
  • When using this product, avoid contact with eyes. 
  • Stop use and ask doctor if: irritation occurs, there is no improvement within 4 weeks (for athletes foot or ringworm) or within 2 weeks (for jock itch)
  • Keep this and all drugs out of reach of children. In case of a accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Directions



• Wash the affected area and dry thoroughly
• Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.
• Supervise children in the use of this product.
• For athletes' 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 athletes foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
• If condition 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 (50 – 86F)
• Close cap tightly after use.


Inactive Ingredients



Alcohol, Butylated hydroxytoluene, Cetostearyl alcohol, Dimethyl sulfoxide, Edetate disodium, Ethylparaben, Glycerol, Mineral oil, Mono-and di-glycerides, Petrolatum, Polyoxyethylene lauryl ether, Purified water


Product Label



image description - image 099 updated

image description - image 099 updated


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