Otc - Active Ingredient
CLOTRIMAZOLE
Aptrimazole
FDA Label NDC 46084-081
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A P J Laboratories Limited for the product Aptrimazole (NDC 46084-081). 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, otc - purpose, otc - keep out of reach of children, indications & usage, do not use:, direction:, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
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.
Indications & Usage
Cures most athlete's foot, jock itch, and ringworm.
Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Do Not Use:
Do not use on children under 2 years of age unless directed by a doctor.
Avoid contact with eyes.
For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Direction:
Clean the affected area and dry thoroughly. Apply a layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
Foe athlete's foot and ringworm, use daily for 4 weeks.
For jock itch, use daily for 2 weeks.
If conditions persist longer, consult a doctor.
This product is not effective on scalp or nails.
Inactive Ingredient
PETROLATUM
LIGHT MINERAL OIL
CETOSTEARYL ALCOHOL
EDETIC ACID
CHLOROCRESOL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
POLYSORBATE 60
CETETH-20
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