FDA.reportPublic FDA data

S-Cream TOLNAFTATE 1%

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:48:08

Label at a glance#

ProductS-Cream TOLNAFTATE 1%
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

• Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) • If used daily, can prevent recurrence of athlete's foot • Relieves symptoms of athlete's foot, including itching, burning and cracking.

Dosage and administration

Wash affected area and dry thoroughly Spray a thin layer over affected area twice daily (morning and night) Supervise children in the use of this product For athlete's foot: 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 conditions persist, consult a doctor. Apply once or twice daily (morning and/or night).

Storage and handling

Store between 20° and 30°C (68°F and 86°).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

PURPOSE

OTC - PURPOSE SECTION

Antifungal

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Disteardimonium hectorite, Fragrance, Isobutane, Isopropyl myristate, SD alcohol 40-B, Sodium bicarbonate.

USES

INDICATIONS & USAGE SECTION

• Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) • If used daily, can prevent recurrence of athlete's foot • Relieves symptoms of athlete's foot, including itching, burning and cracking.

WARNINGS

WARNINGS SECTION

For external use only

Flammable:
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

When using this product
• Do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water 
• Use only as directed 
• Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Stop use and ask a doctor if
• Irritation occurs
• No improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Wash affected area and dry thoroughly

Spray a thin layer over affected area twice daily (morning and night)

Supervise children in the use of this product

For athlete's foot: 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 conditions persist, consult a doctor.

Apply once or twice daily (morning and/or night).

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store between 20° and 30°C (68°F and 86°).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

ANTIFUNGAL CREAM

Manufactured by :

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaf011-1Tolnaf011-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-011-302023-02-08C16284748780-1f386c64a-3d58-0266-e053-dadaa90a7c1aS-Cream TOLNAFTATE 1% ANTIFUNGAL CREAM
73921-011-302023-01-30C16284748780-1f386c64a-3d58-0266-e053-dadaa90a7c1aS-Cream TOLNAFTATE 1% ANTIFUNGAL CREAM

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-01173921-011-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISOBUTANEBXR49TP611IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALCOHOL3K9958V90MIACT
SODIUM BICARBONATE8MDF5V39QOIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f42b730c-51d5-028c-e053-2995a90af170967545f0-8bd3-4f23-bd91-db49436cdf752023-02-08WarningsExact identifier
spl set id: 967545f0-8bd3-4f23-bd91-db49436cdf75

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.