Myco Nail A Antifungal Solution

Manufacturer
Kramer Novis
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:22:13

Label at a glance#

ProductMyco Nail A Antifungal Solution
Active ingredientUNDECYLENIC ACID
Label structure10 sections

Indications and uses

• Proven clinically effective in the treatment of most athlete’s foot, jock itch, and ringworm • For effective relief of itching, scaling, cracking, burning and discomfort.

Dosage and administration

• wash and dry the affected area and dry thoroughly • apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor • 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, and change shoes and socks at least once daily • for athlete’s foot and ringworm, use dai...

Storage and handling

• Store between 15° – 30°C (59° – 86°F). • Tamper Evident Feature: Do not use if safety seal around cap is torn, broken or missing. • Retain carton for full prescribing information.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

• Proven clinically effective in the treatment of most athlete’s foot, jock itch, and ringworm
• For effective relief of itching, scaling, cracking, burning and discomfort.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from fire and flame.

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 a doctor if
• irritation occurs • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• wash and dry the affected area and dry thoroughly
• apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor
• 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, and change shoes and 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, consult a doctor
• this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

• Store between 15° – 30°C (59° – 86°F).
• Tamper Evident Feature: Do not use if safety seal around cap is torn, broken or missing.
• Retain carton for full prescribing information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl acetate, benzyl alcohol, cetylpyridinium chloride, chloroxylenol, eucalyptol, glacial acetic acid, Isopropyl alcohol, propionic acid, propylene glycol, sodium propionate and triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 8 am to 4 pm AST at 1.787.767.2072

SPL UNCLASSIFIED SECTION

Manufactured in the USA for Kramer Novis
San Juan, PR 00917

KramerNovis
Pharmaceuticals within reach of patients

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MycoNailAAntifungalMycoNailAAntifungal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN6
998329undecylenic acid 250 MG/ML Topical SolutionSCD6
998329undecylenic acid 25 % Topical SolutionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-242-30Myco Nail A Antifungal Solution1 in 1 CARTONLIQUID16
52083-242-30Myco Nail A Antifungal Solution30 mL in 1 BOTTLELIQUID306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-242-30ML - Milliliter52083-24222e49e0f-98de-4687-b5e1-4c971c5fc23812014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063P1
BENZYL ACETATEINACTIVE INGREDIENT0ECG3V79ZJ1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49P1
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2Q1
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TK1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
PROPIONIC ACIDINACTIVE INGREDIENTJHU490RVYR1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42IN1
TRIACETININACTIVE INGREDIENTXHX3C3X6731

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52083-24252083-242-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-11-13monthly-update2026-06-03 17:40:12

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PROPIONATESODIUM PROPIONATEDK6Y9P42INCAPSULE / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKPASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
CHLOROXYLENOLCHLOROXYLENOL0F32U78V2QCREAM / TOPICAL0.15 %w/wExact identifier — unii+route
2 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM PROPIONATESODIUM PROPIONATEDK6Y9P42INSUSPENSION / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PLIQUID / SUBCUTANEOUS0.2 %w/vExact identifier — unii+dosage form
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii+route
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii+route
16 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii+route
46 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKSOLUTION / NASAL0.2 mg/1mlExact identifier — unii candidate
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii+route
46 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKDROPS / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PAEROSOL, METERED / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
SODIUM PROPIONATESODIUM PROPIONATEDK6Y9P42INPOWDER, FOR SUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CONCENTRATE / ORAL250 mgExact identifier — unii candidate
28 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PCREAM / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii+route
46 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PSOLUTION / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CAPSULE, EXTENDED RELEASE / ORAL467 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route
16 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PAEROSOL, SPRAY / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
10 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii+route
16 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, EXTENDED RELEASE / ORAL26 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
46 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKDROPS / NASAL0.2 mg/1mlExact identifier — unii candidate
14 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CAPSULE, DELAYED RELEASE / ORAL5.1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii+route
46 equally ranked IID candidates
CHLOROXYLENOLCHLOROXYLENOL0F32U78V2QCREAM / TOPICAL0.15 %w/wExact identifier — unii+route
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route
46 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CAPSULE / ORAL13 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii+dosage form
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
46 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii+dosage form
10 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
SODIUM PROPIONATESODIUM PROPIONATEDK6Y9P42INPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii+route
46 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii+dosage form
10 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii+route
46 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route
46 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PAEROSOL, METERED / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
10 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673SUSPENSION / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM PROPIONATESODIUM PROPIONATEDK6Y9P42INSYRUP / ORAL40 mgExact identifier — unii candidate
14 equally ranked IID candidates
PROPIONIC ACIDPROPIONIC ACIDJHU490RVYROINTMENT / TOPICAL2.7 %w/wExact identifier — unii+route
2 equally ranked IID candidates
CETYLPYRIDINIUM CHLORIDECETYLPYRIDINIUM CHLORIDED9OM4SK49PCAPSULE / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Myco Nail A Antifungal SolutionUNDECYLENIC ACIDKramer Novis550358d7-69e8-4ea3-bcf9-d647c457287d2025-12-04WarningsExact identifier
ndc (package): 52083-242-30
ndc (product): 52083-242
ndc11 (package): 52083024230
spl id: ec997f56-367c-4e57-a2c0-22d4403ae1ad
spl set id: 550358d7-69e8-4ea3-bcf9-d647c457287d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.