Otc - Active Ingredient
clotrimazole 1%
Clotrimazole
FDA Label NDC 0363-3492
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Clotrimazole (NDC 0363-3492). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, warnings, otc - purpose, dosage & administration, otc - keep out of reach of children, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 doctor if: irritation occurs, there is no improvement within 4 weeks (2 weeks for jock itch)
Otc - Purpose
Antifungal
Dosage & Administration
• Use only as directed.
• Clean the affected area with soap and warm water and dry thoroughly.
• Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.
• This product is not effective on the scalp or nails.
• Avoid applying to severely cracked or irritated areas.
• For athlete’s foot: pay special attention to spaces between toes, wear well-fit- ting, 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.
• Super vise children in the use of this product.
• Intended for use by normally healthy adults only.
• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center immediately.
Inactive Ingredient
Aqua (Deionized Water), BHT, Car thamus Tinctorius (Saf flower) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycine Soja (Soybean) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea
Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopher yl Acetate (Vitamin- E), Urea.
Indications & Usage
For the cure of most
• athlete’s foot (tinea pedis)
• ringworm (tinea corporis)
• jock itch (tinea cruris) For relief of
• itching • scaling • cracking • burning • redness • soreness • irritation
• discomforts which may accompany these conditions.
* Please review the disclaimer below.
