SERYNTH MULTI-PURPOSE FUNCUS
84010-119
35c987f7-d0d8-42e8-e063-6294a90ab122
HUMAN OTC DRUG LABEL
May 23, 2025
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
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
Active Ingredient
Tolnaftate 1%
OTC - PURPOSE SECTION
Purpose
Antifungal
STORAGE AND HANDLING SECTION
Other information
Store between 20-25°C (68-77°F)
WARNINGS SECTION
Warnings
For external use only
Extremely Flammable do not use while smoking or near heat or flame.
OTC - DO NOT USE SECTION
Do not use
on children under 2 years of age unless directed by a doctor.
OTC - WHEN USING SECTION
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
Stop Use
·Irritation occurs
·There is no improvement within 4 weeks.
OTC - ASK DOCTOR SECTION
Ask Doctor
·Irritation occurs
·There is no improvement within 4 weeks.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
DOSAGE & ADMINISTRATION SECTION
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
Inactive ingredients
alcohol,benzoic acid,euphorbia hirta whole,phellodendron amurense
bark,phenylephrine hydrochloride,pseudolarix
amabilis bark,salicylic acid,sophora flavescens root.