OMZOK ANTIFUNGAL PEN- undecylenic acid 25% liquid

OMZOK ANTIFUNGAL PEN by

Drug Labeling and Warnings

OMZOK ANTIFUNGAL PEN by is a Otc medication manufactured, distributed, or labeled by Shenzhen Shandian Jingling Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

UNDECYLENIC ACID 25%

PURPOSE

Antifungal

INDICATIONS & USAGE

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

WARNINGS

For external use only.

DO NOT USE

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

WHEN USING

When using this product avoid contact with eyes

STOP USE

Stop use and ask a doctor if irritation occurs or there is noimprovement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OMZOK ANTIFUNGAL PEN 
undecylenic acid 25% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83804-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
MANUKA OIL (UNII: M6QU9ZUH2X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
CLOVE OIL (UNII: 578389D6D0)
ALMOND OIL (UNII: 66YXD4DKO9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83804-007-01	5 in 1 CARTON	08/04/2025
1		3 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/04/2025

Labeler - Shenzhen Shandian Jingling Technology Co., Ltd. (418636058)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Shandian Jingling Technology Co., Ltd.		418636058	manufacture(83804-007)