Active Ingredient
Clotrimazole 1%
The following Structured Product Label (SPL) was submitted to the FDA by Mohnark Pharmaceuticals Inc. for the product Clotrimazole 1% Topical Antifungal Cream (NDC 73715-004). 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 active ingredient, purpose, warnings, stop use and ask doctor if, directions, other information, inactive ingredients, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Clotrimazole 1%
Antifungal
cures most athlete's foot, jock itch and ringworm
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
For external use only
Do not use on children under 2 years of age unless directed by a doctor
When using this product avoid contact with eyes
Stop use and ask a doctor if
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
10 milligrams/gram per application
added dosage information
Adults and children 2 years and older: apply externally to the affected area twice a day (morning and night).
Children under 2 years of age: consult a doctor
If swallowed, get medical help or contact a Poison Control Center right away
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