83804-007 Omzok Antifungal Pen

83804-007 Omzok Antifungal Pen
SPL v1
SPL
SPL Set ID 38edf699-93af-e550-e063-6294a90a368c
Route
TOPICAL
Published
Effective Date 2025-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Tea Tree Oil Manuka Oil Lavender Oil Oregano Leaf Oil Alpha-tocopherol Acetate Jojoba Oil Propolis Wax Clove Oil Almond Oil Aloe Vera Leaf Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-04

Description

UNDECYLENIC ACID 25%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

Dosage and 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.

Description

UNDECYLENIC ACID 25%

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product avoid contact with eyes

Section 50570-1

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

Section 51727-6

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)

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

UNDECYLENIC ACID 25%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)



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.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

UNDECYLENIC ACID 25%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)