Otc - Active Ingredient
UNDECYLENIC ACID 25%
Omzok Antifungal Pen Liquid
FDA Label NDC 83804-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Omzok Antifungal Pen (NDC 83804-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
For the treatment of athlete's foot, jock itch, and ringworm
Warnings
For external use only.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed bya doctor.
Otc - When Using
When using this product avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or there is noimprovement within 4 weeks
Otc - 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)
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
