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DRUG FACTS

Manufacturer
Adwill Labs Inc | PhytogenX, Inc.
Effective date
2026-06-01
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
daily-update
Hydrated at
2026-06-04 05:10:10

Label at a glance#

ProductRemedy Nails
Active ingredientUNDECYLENIC ACID
Label structure10 sections

Indications and uses

Treats cuticle and skin fungal infections. Heals and moisturizes cuticles and skin. Athlete's foot treatment. Relieves itching, burning and cracking.

Dosage and administration

Wash and dry affected area. Apply a thin layer over affected area twice daily or as directed by a doctor. Apply enough medication to cover the affected area and surrounding skin. Wash hands after use. For maximum results, use twice daily or as instructed. Discontinuing use of this medication may allow recurrence of infection. If condition persists, consult your doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid USP 10%

PURPOSE:

OTC - PURPOSE SECTION

Anti-Fungal

USES:

INDICATIONS & USAGE SECTION

Treats cuticle and skin fungal infections.

  • Heals and moisturizes cuticles and skin.
  • Athlete's foot treatment.
  • Relieves itching, burning and cracking.

WARNINGS: FOR EXTERNAL USE ONLY.

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • Consult your doctor if you are pregnant before using this product.
  • It is not known whether this drug passes into breast milk.
  • Consult your doctor before breast feeding.
  • If swallowed, call Poison Control Center immediately.

STOP USE AND ASK A DOCTOR IF:

OTC - STOP USE SECTION

Irritation occurs.

  • No improvement within 2 weeks.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Wash and dry affected area.

  • Apply a thin layer over affected area twice daily or as directed by a doctor.
  • Apply enough medication to cover the affected area and surrounding skin.
  • Wash hands after use.
  • For maximum results, use twice daily or as instructed.
  • Discontinuing use of this medication may allow recurrence of infection.
  • If condition persists, consult your doctor.

CAUTION:

SPL UNCLASSIFIED SECTION

Do not accept if safety seal is broken or missing.

  • Store at room temperature 60-85F.
  • Keep in tight, light resistant container.

ALLERGIC REACTIONS:

SPL UNCLASSIFIED SECTION

Contact doctor if unusual reactions to this medicine occur.

  • This product does not contain FD&C Yellow #5 or FD&C Yellow #6.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Mineral Oil, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Linalool, Carthamus Tinctorius (Safflower) Seed Oil, Limonene, Aleurites Moluccana (Kukui) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Algae Extract.

Principal Display Panel - 15 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr.'s REMEDY®
Therapeutic Cuticle Oil

Lavender
Safflower
Tea Tree Oil
Algae Extract

Nourishing
Anti-Fungal
Treatment

15mL

Principal Display Panel - 15 mL Bottle Label
Principal Display Panel - 15 mL Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72222-22472222-224-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SAFFLOWER OIL65UEH262ISIACT
TEA TREE OILVIF565UC2GIACT
GRAPE SEED OIL930MLC8XGGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAVENDER OILZBP1YXW0H8IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132024-11-07full-release2026-06-01 00:35:35

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
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsExact identifier
ndc (package): 72222-224-10
ndc (product): 72222-224
ndc11 (package): 72222022410
spl id: a907968b-6a37-44e9-9e7a-aa8bfd57cec6
spl set id: 4e87b76c-c430-466a-bc30-fe1785c7c660

Reported adverse events (FAERS/openFDA)#

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