MedPath

ELSATIMY MULTI-PURPOSE TREATMENT

84010-166 update pack

Approved
Approval ID

3b0e1aa4-c3a6-65a5-e063-6294a90a38a1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

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

Tolnaftate 1% MULTI-PURPOSE TREATMENT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-166
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate 1% MULTI-PURPOSE TREATMENT
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (7)

PSEUDOLARIX AMABILIS BARKInactive
Code: 49G13A93VE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDRACRYLIC ACIDInactive
Code: C4ZF6XLD2X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TOLNAFTATEActive
Quantity: 1 g in 100 mL
Code: 06KB629TKV
Classification: ACTIB
RESORCINOLInactive
Code: YUL4LO94HK
Classification: IACT
EUPHORBIA HIRTA WHOLEInactive
Code: L13YF113GN
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/29/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/29/2025

Use

For most Nail Fungus,Relieves itching, sorenes,discoloration, thickening, splitting and nai brittleness.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/29/2025

Ask Doctor

irritation occurs, there is no improvement within 4 weeks

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 7/30/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 7/29/2025

Warnings

For external use only.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/29/2025

When Using

avoid contact with eyes.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/29/2025

Directions

Use daily for 4 weeks or more. 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, ventil ated shoes, and socks at least once daily. To prevent reinfection, continue use for 2 weeks after symptoms resolve.Apply to skin around the nail and cuticle.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/29/2025

Active Ingredient

Tolnaftate 1%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/29/2025

Inactive ingredients

water,euphorbia hirta whole,glycerin,hydracrylic acid,pseudolarix amabilis bark,resorcinol,etc.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/29/2025

Purpose

Antifungal

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/29/2025

Do not use

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/29/2025

Stop Use

irritation occurs, there is no improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/29/2025

Keep Oot Of Reach Of Children

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/29/2025

Other information

Store at room temperature 15-30℃ (59-86F)

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