Active Ingredient
Clotrimazole 1%
Clotrimazole Cream
FDA Label NDC 80489-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ol Pharma Tech,llc for the product Clotrimazole (NDC 80489-002). 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, uses, warnings, do not use:, when using this product, stop use and ask your doctor if:, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
- 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:
Do not use on children under 2 years of age unless directed by a doctor.
When Using This Product
avoid contact with the eyes
Stop Use And Ask Your Doctor If:
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
- wash the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a
- supervise children in the use of this product
- for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes,
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- this product is not effective on the scalp or nails
doctor
and change shoes and socks at least once daily
if condition lasts longer, contact a doctor
Other Information
- store at controlled room temperature 59°-86°F (15°-30°C).
- before using any medication, read all label directions. Keep carton, it contains important information
Inactive Ingredients
sodium cetostearyl sulfate, cetostearyl alcohol, stearic acid, trolamine, mineral oil , ceteareth-12, propylene glycol, methyl parabeen, propyl paraben, EDTA disodium, vitamin E, water
For Questions:
www.drspharmacyusa.com
Package Label.Principal Display Panel
original strenghth
Antifungal cream
Clotrimazole (Clotrimazole)
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