FDA Label for Clotrimazole 1% Topical Antifungal Cream
View Indications, Usage & Precautions
Clotrimazole 1% Topical Antifungal Cream Product Label
The following document was submitted to the FDA by the labeler of this product Mohnark Pharmaceuticals 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 1%
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.
Stop Use And Ask Doctor If
irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Directions
- 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
Other 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
Inactive Ingredients
benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
Dosage And Administration
10 milligrams/gram per application
added dosage information
Indications And 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
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
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