MedPath

SERYNTH MULTI-PURPOSE FUNCUS

84010-119

Approved
Approval ID

35c987f7-d0d8-42e8-e063-6294a90ab122

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 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 FUNCUS

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-119
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate 1% MULTI-PURPOSE FUNCUS
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (9)

TOLNAFTATEActive
Quantity: 1 g in 100 mL
Code: 06KB629TKV
Classification: ACTIB
PHELLODENDRON AMURENSE BARKInactive
Code: PBG27B754G
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEInactive
Code: 04JA59TNSJ
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EUPHORBIA HIRTA WHOLEInactive
Code: L13YF113GN
Classification: IACT
PSEUDOLARIX AMABILIS BARKInactive
Code: 49G13A93VE
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Use

· Proven clinically effective in the treatment of most athlete's foot (tinea pedis)
· Helps prevent most athlete's foot with daily use
· For effective relief of itching, cracking, burning,scaling and discomfort

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active Ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Antifungal

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/23/2025

Other information

Store between 20-25°C (68-77°F)

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

For external use only
Extremely Flammable do not use while smoking or near heat or flame.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

Do not use

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/23/2025

When Using

this product avoid contact with the eyes
·Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
·Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/23/2025

Stop Use

·Irritation occurs
·There is no improvement within 4 weeks.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/23/2025

Ask Doctor

·Irritation occurs
·There is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/23/2025

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Directions

·Wash the affected area and dry thoroughly
·Shake can well and spray a thin layer over affected area twice daily (morning and night)
·Supervise children in the use of this product
·pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once
daily
·Use daily for 4 weeks; if condition persists longer, ask a doctor
·To prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
·This product is not effective on the scalp or nails.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

alcohol,benzoic acid,euphorbia hirta whole,phellodendron amurense bark,phenylephrine hydrochloride,pseudolarix
amabilis bark,salicylic acid,sophora flavescens root.

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SERYNTH MULTI-PURPOSE FUNCUS - FDA Drug Approval Details