FDA.reportPublic FDA data

Antifungal Cream

Manufacturer
BluePoint Laboratories | Gopaldas Visram & Co., Ltd
Effective date
2023-11-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:02:25

Label at a glance#

ProductAntifungal Cream
Active ingredientCLOTRIMAZOLE
Label structure13 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of cream over affected area twice daily (morning and night) or as directed by a doctor. 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.

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 Preserve in tight containers See crimp of tube or carton for Lot Number and Expiry Date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1 %

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

OTC - PURPOSE SECTION

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet.

Warnings

WARNINGS SECTION

For external use only

Do not use:

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

When using this product

  • Avoid contact with eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks when used for the treatment of jock itch.
  • there is no improvement within 4 weeks when used for athlete's foot or ringworm.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 cream over affected area twice daily (morning and night) or as directed by a doctor.
  • 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.

DOSAGE & ADMINISTRATION SECTION

  • For athletes 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.

Other Information

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
  • Preserve in tight containers
  • See crimp of tube or carton for Lot Number and Expiry Date

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cetostearyl Alcohol, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether,

Propylene Glycol, Propylparaben, Purified water, White petrolatum

Questions?

OTC - QUESTIONS SECTION

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited,

Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/739

For BluePoint Laboratories

Rev 09/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clotrimazole 1% 0.5oz 68001-475-45

0.5 tube0.5 tube0.5 carton0.5 carton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 oz carton1 oz cartonClotrimazole 1% 1oz 68001-475-47

1 oz tube1 oz tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN5
309367clotrimazole 10 MG/ML Topical CreamSCD5
309367clotrimazole 1 % Topical CreamSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-475-45Antifungal Cream1 in 1 CARTONCREAM15
68001-475-45Antifungal Cream14.2 g in 1 TUBECREAM14.25
68001-475-46Antifungal Cream1 in 1 CARTONCREAM15
68001-475-46Antifungal Cream15 g in 1 TUBECREAM155
68001-475-47Antifungal Cream28.4 g in 1 TUBECREAM28.45
68001-475-47Antifungal Cream1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-475ANTIFUNGAL CREAM (ANTIFUNGAL) CREAM [BLUEPOINT LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20231118_b4c4240f-f84c-ec5e-e053-2a95a90aa082.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-475-45GM - Gram68001-4756063da07-113a-43f8-9344-e8bd6787119912021-08-05
68001-475-47GM - Gram68001-475f1c22db1-ee32-49fa-8a52-cdcba1edd83112021-08-05

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68001-47568001-475-47, 68001-475-46, 68001-475-45

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
MINERAL OILT5L8T28FGPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
ndc (package): 68001-475-45
ndc (package): 68001-475-47
ndc (package): 68001-475-46
ndc (product): 68001-475
ndc11 (package): 68001047547
ndc11 (package): 68001047545
ndc11 (package): 68001047546
spl id: 097d120f-44a3-3b38-e063-6294a90a8e70
spl set id: b4c4240f-f84c-ec5e-e053-2a95a90aa082

Reported adverse events (FAERS/openFDA)#

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