MedPath

iShancare NAIL FUNGUS SERUM

Approved
Approval ID

361a61cd-150c-5fcc-e063-6394a90ad553

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jan 1, 2025

Manufacturers
FDA

Shenzhen Ishan Technology Co., Ltd

DUNS: 554484192

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NAIL FUNGUS SERUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73076-163
Product Classification
G
Generic Name
NAIL FUNGUS SERUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2025
FDA Product Classification

INGREDIENTS (5)

CHLORHEXIDINE ACETATEActive
Quantity: 2 g in 100 g
Code: 5908ZUF22Y
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
2-(TRIFLUOROMETHYL)BENZOIC ACIDInactive
Code: 0R1CK7MZUA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TRICLOSANInactive
Code: 4NM5039Y5X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Lable

fungus

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

Directions

  • Before use, clean the affected area with soap and soak the nail in warm waterto soften it.

  • For toenail fungus, scrape the dirt off the nail and gently file the thickened partof the fungal nail until it's flat (be careful not to damage the nail bed).

  • Use twice a day, morning and evening.

  • Repeat this process 2-3 times a day until a healthy nail begins its gradualregeneration.

  • For best results, use continuously for 6 weeks.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

Active ingredient

Chlorhexidine Acetate 2%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

Inactive ingredient

Purified water, Benzoic acid, Boric acid, Ethanol, Triclosan.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2025

Keep out of reach of children.

if swallowed, call poison control or seek medical help.

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 1/1/2025

Ask a doctor if

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 1/1/2025

Stop use and ask a doctor if

pain worsens or persists, or if youexperience any of these symptoms: burning, itching, rash, or other changes in theskin where the product was placed.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

USES

Effectively treats nail fungus, discoloration, splitting, thickening, crumbling and brittleness.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/1/2025

Other information

Store at room temperature 59-86°F(15-30°C)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025

Dosage & administration

Apply 2-3 times a day

USER SAFETY WARNINGS SECTION

LOINC: 54433-8Updated: 1/1/2025

When using this product

Do not wear this product directly on skin.

Be aware of low-temperature burns.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025

Warning

Warnings: For external use only

  • Do not use on children under 2 years of age unless directed by a doctor.

  • Avoid contact with eyes when using this product, if contact occurs rinse thoroughly with water

  • Stop use and ask a doctor if
    lrritation occurs or discomfort persists.Keep out of reach of children

  • If swallowed, call a poison control centre or seek medical attention immediately.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 3/24/2025

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