FDA.reportPublic FDA data

OMZOK ANTIFUNGAL PEN

Manufacturer
Shenzhen Shandian Jingling Technology Co., Ltd.
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:14

Label at a glance#

ProductOMZOK ANTIFUNGAL PEN
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed bya 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 noimprovement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. lf swallowed, get medical helpor contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION


Read all warnings and directions oUse only as directed
Clean the affected area with soap and water and drythoroughly
Remove cap from pen e Twist the base of the pen,with brush pointing downward, until product dispenses
Apply a thin layer of the product over the affected area twicedaily (morning and night) or as directed by a doctor
For athlete's foot, pay special attention to spaces betweenthe toes; wear well-fitting, ventilated shoe, and change shoesand socks at least once daily.

INACTIVE INGREDIENT SECTION

ALOE VERA LEAF
SWEET ALMOND OIL
JOJOBA OIL
TEA TREE OIL
MANUKA OIL
CLOVE BUD OIL
LAVENDER OIL
OREGANO OIL
PEPPERMINT OIL
PROPOLIS WAX
ALPHA.-TOCOPHEROL ACETATE (vitamin E)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83804-007-01OMZOK ANTIFUNGAL PEN3 mL in 1 APPLICATORLIQUID31
83804-007-01OMZOK ANTIFUNGAL PEN5 in 1 CARTONLIQUID51

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83804-00783804-007-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
MANUKA OILM6QU9ZUH2XIACT
LAVENDER OILZBP1YXW0H8IACT
OREGANO LEAF OIL7D0CGR40U1IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
JOJOBA OIL724GKU717MIACT
PROPOLIS WAX6Y8XYV2NOFIACT
CLOVE OIL578389D6D0IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
ALMOND OIL66YXD4DKO9IACT
ALOE VERA LEAFZY81Z83H0XIACT
PEPPERMINT OILAV092KU4JHIACT

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
OMZOK ANTIFUNGAL PENUNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.38edf699-93af-e550-e063-6294a90a368c2025-07-02WarningsExact identifier
ndc (package): 83804-007-01
ndc (product): 83804-007
ndc11 (package): 83804000701
spl id: 38edf699-93b0-e550-e063-6294a90a368c
spl set id: 38edf699-93af-e550-e063-6294a90a368c

Reported adverse events (FAERS/openFDA)#

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