Antifungal Cream

Manufacturer
BluePoint Laboratories | Gopaldas Visram & Co., Ltd
Effective date
2022-05-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:00:21

Label at a glance#

ProductAntifungal Cream
Active ingredientTOLNAFTATE
Label structure13 sections

Indications and uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directy by a doctor. supervise children in the use of this product.

Storage and handling

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal Store at room temperature See crimp of tube or carton for lot number and Expiry Date

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose







Tolnaftate 1.0% Antifungal

Uses

OTC - PURPOSE SECTION

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort

Warnings For External use only

WARNINGS SECTION

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

For external use only

When using this productavoid conatct with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

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

Directions

INDICATIONS & USAGE SECTION

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directy by a doctor.
  • supervise children in the use of this product.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

  • 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
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Keep Out Of Reach Of Children

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Ceteth-20, Cetostearyl alcohol, Chlorocresol, Mineral Oil, Propylene glycol, Purified Water, Sodium Phosphate, Monobasic Dihydrate, White Petrolatum.

OTC - QUESTIONS SECTION

Contact 1-800-707-4621

STORAGE AND HANDLING SECTION

  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • Store at room temperature
  • See crimp of tube or carton for lot number and Expiry Date

1% Tolnaftate Cream, USP Carton (1oz/28.4g) NDC 68001-478-45

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate 1oz CartonTolnaftate 1oz Carton

1% Tolnaftate Cream, USP Tube Label (1oz/ 28.4g) NDC 68001-478-45

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate 1oz LabelTolnaftate 1oz Label

1% Tolnaftate Cream, USP Carton (0.5oz/ 14.2g) NDC 68001-478-46

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate 0.5oz CartonTolnaftate 0.5oz Carton

1% Tolnaftate Cream, USP Tube Label (0.5oz/ 14.2g) NDC 68001-478-46

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate 0.5oz LabelTolnaftate 0.5oz Label

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68001-47868001-478-45, 68001-478-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
0439da7e-deb7-9cbc-e063-6294a90a1c76b5904d39-ba21-525b-e053-2a95a90a61f32023-09-04WarningsExact identifier
spl set id: b5904d39-ba21-525b-e053-2a95a90a61f3

Reported adverse events (FAERS/openFDA)#

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