FDA Label for Dermasana
View Indications, Usage & Precautions
Dermasana Product Label
The following document was submitted to the FDA by the labeler of this product Omg Medical Group, Llc. 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.
Warnings
do not used on children under two years of age except under the advice and supervision of a doctor
stop use and ask a doctor if irritation occurs, if conditions worsens, or there is not improvement within four weeks.
for external use only
avoid contact with eyes, scalp, vagina, penis, scrotum and anus
do not ingest
do not use on open wounds
in case of accidental ingestion contact a physician, emergency medical
do not use if you are known to be sensitive to any of the ingredients in this product
Active Ingredient
miconazole nitrate 2% USP
triclosan 0.3% USP
Purpose
topical antifungal
topical antibacterial
Otc - Keep Out Of Reach Of Children
Keep this and all medications our of the reach of children
Directions
shake well before using
clean and dry affected areas
apply twice per day or as recommended by your doctor
with the brush applicator a thin layer of the product to the affected areas
Uses
antifungal drying agent
antibacterial drying agent
is indicated in the treatment of most fungi
athlete's foot (tinea pedis)
ringworm (tinea corporis)
jock itch (tinea cruris)
candida albicans
trichophyton rubrum
malassezia furfur
trichophyton mentagrophytes
epidemophyton floccsum
is indicated for the treatment of most bacteria
gram positive bacteria (such as staphyloocccous aureus)
is indicated for certain methicillin resistant saphylococcus aureus (MRSA) isolates
is indicated for most coagulase-negative staphylococci
beta hemolytic streptococci
corynebacterium species
clostridium species
anaerobic gram-negative bacilli (such as bacteriodes fragilis)
Other Information
store at controlled room temperature 15-30 degrees celcius (59-86 degrees farenhight)
protect from heat
keep from freezing, if freezing occurs, thaw out at room temperature and shake well to mix contents back to a solution
Inactive Ingredient
acetic acid, aqua (deionized water), benzyl alcohol, c13-14 isoparaffin, ethylhexylglycerin, laureth 7, parfum, phenoxyethanol, polyacrylamide, polysorbate 20, sd-alcohol 40B
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