Update 85569-017-01--192

Manufacturer
100 KARMA INC
Effective date
2026-07-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:13

Label at a glance#

ProductTreatonic Antifungal Pen
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

  • For the treatment of most athlete's foot(tinea pedis), jock itch(tinea cruris) and ringworm(tinea corporis).
  • For effective relief of itching, cracking and burning skin.

WARNINGS SECTION

For external use only

Do not use

on children under 2 years of age unless directed by a doctor.

When using this product

avoid contact with the eyes

Stop and ask a doctor if

irritation occurs or if there isno improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.If condition persists longer,consult a doctor. This product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

store at room temperature.

INACTIVE INGREDIENT SECTION

Water, Euphorbia Hirta Whole, Glycerin, Hydracrylic Acid,Isopropyl Myristate, Tea Tree Oil, Pseudolarix Amabilis Bark, Resorcinol

OTC - QUESTIONS SECTION

Email: service@treatonic.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85569-01785569-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-27daily-update2026-07-15 00:32:55

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
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
ndc (package): 85569-017-01
ndc (product): 85569-017
ndc11 (package): 85569001701
spl id: 55b69f19-20f6-4203-e063-6394a90a43b0
spl set id: 52d89172-e8a7-70c0-e063-6294a90a3563

Reported adverse events (FAERS/openFDA)#

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