Forticept Antifungal Balm

Manufacturer
Cosco International, Inc.
Effective date
2016-05-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:45:54

Label at a glance#

ProductForticept Antifungal Balm
Active ingredienttolnaftate
Label structure7 sections

Dosage and administration

Read all package directions and warnings before use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Apply a thin layer of FORTICEPT TM COOLING BALM over the affected area twice daily (morning and night), or as directed by a doctor. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least on...

Label contents#

Full prescribing information#

Active Ingredient/Purpose

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1% w/w........................Antifungal

Uses

OTC - Purpose Section

Proven clinically effective in the treatment and prevention of most athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris).

Warnings

WARNINGS SECTION

For external use only

otc - do not use section

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

otc - when using section

When using this product avoid contact with eyes.

indications & usage section

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

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.

Directions

dosage & administration section

  • Read all package directions and warnings before use. Use only as directed.
  • Clean the affected area with soap and warm water and dry thoroughly.
  • Apply a thin layer of FORTICEPTTM COOLING BALM over the affected area twice daily (morning and night), or as directed by a doctor.
  • For athlete's foot, pay special attention to spaces between 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. If condition persists longer, consult a doctor.
  • Intended for use by normally healthy individuals only.
  • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
  • Supervise children in the use of this product.

SPL UNCLASSIFIED SECTION

Other Information  store between 20° - 25°C (68° - 77°F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acticire®, Capric Caprylic Triglyceride, Dimethicone, Eucalyptus Oil, Glyceryl Behenate, Glyceryl Stearate, Lavender Oil, LexFeel® N5, Methyl Lactate, PEG 40 Hydrogenated Castor Oil, Polyhexanide, Sunflower Oil, Tea Tree Oil, Water

30g

package label.principal display panel

30g30g

60g

package label.principal display panel

60g60g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN5
313423tolnaftate 10 MG/ML Topical SolutionSCD5
313423tolnaftate 1 % Topical SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52261-0100-02021-01-29C16284748780-1ba0f9c33-54ef-a910-e053-dadaa90a0b85Drug Facts
52261-0100-12021-01-29C16284748780-1ba0f9c33-54ef-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52261-0100-0Forticept Antifungal Balm30 g in 1 TUBEliquid305
52261-0100-1Forticept Antifungal Balm60 g in 1 TUBEliquid605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52261-0100FORTICEPT ANTIFUNGAL BALM (TOLMAFTATE) LIQUID [COSCO INTERNATIONAL, INC.]5Legacy NDC, 2 package rows20160512_ec71e0cb-37c7-42ff-a942-fe69af2eb92a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-010052261-0100-0, 52261-0100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
9987f223-4261-43a1-99d0-9219140c8c8aec71e0cb-37c7-42ff-a942-fe69af2eb92a2016-05-11WarningsExact identifier
spl id: 9987f223-4261-43a1-99d0-9219140c8c8a
spl set id: ec71e0cb-37c7-42ff-a942-fe69af2eb92a

Reported adverse events (FAERS/openFDA)#

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