Otc - Active Ingredient
Clotrimazole 1%
1med Clotrimazole 1% Antifungal Cream
FDA Label NDC 73750-095
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Qyk Brands Llc for the product 1med Clotrimazole 1% Antifungal Cream (NDC 73750-095). 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, warnings, otc - stop use, instructions for use, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
cures most athlete's foot, jock itch and ringworm
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Warnings
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
irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Instructions For Use
wash affected area and dry thoroughly
apply a thin layer over affected area twice daily (morning and night)
supervise children in the use of this product
for athlete's foot, pay special attention to the spaces between the toes, wear well fitting, ventilated shoes and change socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails
Dosage & Administration
10 milligrams/gram per application
Inactive Ingredient
benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
Other Safety Information
To open: unscrew cap, remove liner seal and replace cap
Store at USP controlled room temperature 20-25°C (68-77°F)
see carton or tube crimp for lot number and expiration date
Indications & Usage
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
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Package Label.Principal Display Panel
73750-095-01 (73750 095 01)
73750-095-05 (73750 095 05)
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