Dermasana
FDA Label NDC 55992-023

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Omg Medical Group, Llc for the product Dermasana (NDC 55992-023). 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 warnings, active ingredient, purpose, otc - keep out of reach of children, directions, uses, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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