FDA.reportPublic FDA data

Lunavia Antifungal Spray

Manufacturer
XF Agencija Limited
Effective date
2025-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:04

Label at a glance#

ProductLunavia Antifungal
Active ingredientUNDECYLENIC ACID
Label structure12 sections

Indications and uses

For the treatment of athlete's foot, jock itch, and ringworm.

Dosage and administration

■ Read all warnings and directions. ■ Use only as directed. ■ Clean the affected area with soap and water and dry thoroughly. ■ Remove cap from Bottle. ■ Spray the bottle on and inside shoes, socks, and feet until all areas are covered. ■ Spray a thin layer of the product over the contaminated area twice daily (morning and night) or as directed by a doctor. ■ For athlete's foot, pay special attention to spaces bet...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For the treatment of athlete's foot, jock itch, and ringworm.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

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

■ Read all warnings and directions.

■ Use only as directed.
■ Clean the affected area with soap and water and dry thoroughly.

■ Remove cap from Bottle.

■ Spray the bottle on and inside shoes, socks, and feet until all areas are covered.

■ Spray a thin layer of the product over the contaminated area twice daily (morning and night) or as directed by a doctor.

■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

Other information

SPL UNCLASSIFIED SECTION

■ Store at 15°-30°C (59° - 86°F)
■ Keep cap on bottle when not in use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized water, Polypropylene Glycol, Melaleuca Alternifolia Leaf Oil (Tea Tree), Eucalyptus Globulus Leaf oil, Mentha Piperita (Peppermint) Oil, Citrus Limon (Lemon) Oil, Clove Bud Oil.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Shoe SprayLabel Shoe Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1050671undecylenic acid 25 % Topical SprayPSN1
1050671undecylenic acid 250 MG/ML Topical SpraySCD1
1050671undecylenic acid 25 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85210-002-01Lunavia Antifungal1 in 1 BOXSPRAY11
85210-002-01Lunavia Antifungal120 mL in 1 BOTTLESPRAY1201

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85210-00285210-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
LEMON OIL, COLD PRESSEDI9GRO824LLIACT
CLOVE OIL578389D6D0IACT

Source Document#

Source XML

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
Lunavia AntifungalUNDECYLENIC ACID 25%XF Agencija Limited55891d2f-e2b8-4d9f-8140-dc258926ed902025-06-13WarningsExact identifier
ndc (package): 85210-002-01
ndc (product): 85210-002
ndc11 (package): 85210000201
spl id: 7bc16802-1505-4a36-af58-dc97c93e96f2
spl set id: 55891d2f-e2b8-4d9f-8140-dc258926ed90

Reported adverse events (FAERS/openFDA)#

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