Nail Md
FDA Label NDC 55992-717

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 Nail Md (NDC 55992-717). 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, inactive ingredient, otc - active ingredient, otc - purpose, uses, directions, other information, otc - 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

Warnings

do not use on children under two years of age except under the advce and supervision of a doctor

stop use and ask a doctor if irritation occurs, if condition worsesn, 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

Inactive Ingredient

aqua (deionized water), biotin, dimethyl sulfone (msm), ethyoxydiglycol, ethylhexylglycerin, hydrolyzed keratin proteins, hydroxyethylcellulose, phenoxyethanol, polysorbate 20, sd alcohol 40B

Otc - Active Ingredient

miconazole nitrate 2% USP

Otc - Purpose

Topical antifungal

Uses

antifungal drying agent

is indicated for candida albicans, trichophyton rubrum, malassezia furfur, trichophyton mentagrophytes

as well as somegram postivie bacteria

lessens the signs of nail dystophy (nail damage caused by trauma or diseas such as fungal infection)

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 making sure to coat both the nail and cuticle completely

Other Information

store at controlled room temperature 15-30 degrees celsius (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

Otc - Keep Out Of Reach Of Children

keep this and all medications out of the reach of children

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