FDA.reportPublic FDA data

FUNGAL NAIL TREATMENT KIT- Cream-205

Manufacturer
GETHSEMANE BRANCH CORPORATION
Effective date
2026-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-08 02:00:59

Label at a glance#

ProductFUNGAL NAIL TREATMENT kit .cream.
Active ingredientSTEMONA JAPONICA ROOT, ATRACTYLODES LANCEA ROOT, COPTIS CHINENSIS ROOT, CAMPHOR (NATURAL), BORNEOL, PROPYLENE GLYCOL, SALICYLIC ACID, SOPHORA FLAVESCENS ROOT, PSEUDOLARIX AMABILIS BARK
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

  • Pseudolarix Amabilis Bark 1%
  • Stemona Japonica Root 2%
  • Coptis Chinensis Root 1%
  • Sophora Flavescens Root 1.5%
  • Atractylodes Lancea Root 1%
  • Borneol 1.5%
  • Camphor (Natural) 1%
  • Propylene Glycol 1.5%
  • Salicylic Acid 1%

OTC - PURPOSE SECTION

  • Anti-Fungal
  • Anti-Fungal
  • Anti-Fungal
  • Anti-Bacterial
  • Anti-Bacterial
  • Reduces itching
  • Reduces itching
  • Lubricating & Moisturizing
  • Cleanse Skin Tissue

DOSAGE & ADMINISTRATION SECTION

Hinder fungal and bacterial growth, reduces itching, cleanse skin tissue.

WARNINGS SECTION

For external use only.

Do not use

  • on irritated skin on any area that is infected or reddened
  • Do not use it if pregnant or if there is any allergic reaction to this product
  • Avoid contact with eyes.

Ask a doctor before you use

If you have diabetes or poor blood circulation

Stop use and ask a doctor

If discomfort persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If product gets into eyes, flush with water for 15 minutes
  • If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE SECTION

  • Wash feet thoroughly with warm water, and gently file thickened par of the fungal nail with a nail file until it's flat
  • Apply a layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail
  • After the liquid has been absorbed, apply a layer of the cream to the infected parts of the nail
  • Repeat the process if necessary once a day.

INACTIVE INGREDIENT SECTION

White Petrolatum, Camphor Oil, White, Stearic Acid, Glyceryl Monostearate, Carbomer

OTC - QUESTIONS SECTION

NEWMIST LLC
EARTH CITY, MISSOURI 63045
www.inaturalvine.com
service@inaturalvine.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 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87870-00287870-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
STEMONA JAPONICA ROOTFXG254HF10ACTIB
ATRACTYLODES LANCEA ROOTCAZ6282J2OACTIB
GLYCERYL MONOSTEARATE230OU9XXE4IACT
COPTIS CHINENSIS ROOTCXS4LJR7ELACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
BORNEOLM89NIB437XACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
CARBOMER0A5MM307FCIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KACTIB
PSEUDOLARIX AMABILIS BARK49G13A93VEACTIB
CAMPHOR OIL, WHITE26P3H26Z9XIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
ndc (package): 87870-002-01
ndc (product): 87870-002
ndc11 (package): 87870000201
spl id: 56c9d9fa-09ae-e26a-e063-6394a90a0ed9
spl set id: 56c9d9fa-09ad-e26a-e063-6394a90a0ed9
FUNGAL NAIL TREATMENT kitPSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56cb7085-87d8-4273-e063-6394a90ac5df2026-07-17WarningsExact identifier
ndc (package): 87870-002-01
ndc11 (package): 87870000201

Reported adverse events (FAERS/openFDA)#

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