MedPath

NATUHEAL MULTI-PURPOSE TREATMENT

84010-126

Approved
Approval ID

3606b820-2aa4-3203-e063-6394a90a7316

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 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 Code84010-126
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate 1% MULTI-PURPOSE TREATMENT
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
FDA Product Classification

INGREDIENTS (7)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/26/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/26/2025

Use

Cures most Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis). Relieves itching, scaling, cracking, burning,
redness, Sorenes, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) withdaily use.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/26/2025

Active Ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2025

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 5/26/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/26/2025

Do not use

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/26/2025

When Using

avoid contact with eyes.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/26/2025

Stop Use

if irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/26/2025

Ask Doctor

if irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/26/2025

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: 5/26/2025

Directions

For athlete's foot and ringworm:use daily for 4 weeks. 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 child ren in the use of this product. This product
is not effective for the treatment of ringworm of the scalp or nails. For athlete's
foot: pay special attention to spaces between the toes, wear well-fitting, ventil ated shoes, and change shoes and socks at least once daily. To prevent athlete's foot, apply once or twice daily (morning and/or night). Apply to skin around the nail and cuticle.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/26/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/26/2025

Inactive ingredients

Water, Euphorbia Hirta Whole, Glycerin, Hydracrylic acid, Pseudolarix Amabilis Bark, Resorcinol.

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NATUHEAL MULTI-PURPOSE TREATMENT - FDA Drug Approval Details