Antifungal Cream

Manufacturer
BluePoint Laboratories | Gopaldas Visram & Co., Ltd
Effective date
2023-11-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:25

Label at a glance#

ProductAntifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure18 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis). For the treatment of superficial skin infections caused by yeast (Candida Albicans) Relieves itching, scaling, burning, 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 the product 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. For athlete's foot and ringworm, use daily for 4 weeks. Fo...

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 controlled room temperature. Preserve in tight container. See crimp of tube or carton for Lot Number and expiry date.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by yeast (Candida Albicans)
  • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 and 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 Centre right away.

Directions

DOSAGE & ADMINISTRATION 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 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.
  • 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 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 controlled room temperature.
  • Preserve in tight container.
  • See crimp of tube or carton for Lot Number and expiry date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether 20, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum.

Questions?

OTC - QUESTIONS SECTION

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram and 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

2% Miconazole Nitrate Cream, USP Carton 1oz (28.4g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

2% Miconazole Nitrate Cream, USP Tube 1oz (28.4g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 oz tube1 oz tube

2% Miconazole Nitrate Cream, USP Carton 0.5oz (14.2g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.5 carton0.5 carton

2% Miconazole Nitrate Cream, USP Tube 0.5oz (14.2g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.5 tube0.5 tube

2% Miconazole Nitrate Cream, USP Carton 1.5oz (42.5g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.5 carton1.5 carton

2% Miconazole Nitrate Cream, USP Tube 1.5oz (42.5g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.5 tube1.5 tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN3
998483miconazole nitrate 20 MG/ML Topical CreamSCD3
998483miconazole nitrate 2 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-481-45Antifungal Cream1 in 1 CARTONCREAM13
68001-481-45Antifungal Cream28.4 g in 1 TUBECREAM28.43
68001-481-47Antifungal Cream42.5 g in 1 TUBECREAM42.53
68001-481-47Antifungal Cream1 in 1 CARTONCREAM13
68001-481-48Antifungal Cream1 in 1 CARTONCREAM13
68001-481-48Antifungal Cream14.2 g in 1 TUBECREAM14.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-481ANTIFUNGAL CREAM (ANTIFUNGAL) CREAM [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 6 package rows20231118_b564f971-2a9b-a605-e053-2995a90aee69.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-481-45GM - Gram68001-481ba768649-6724-4ed0-ad34-e2e98517b08712022-10-06
68001-481-47GM - Gram68001-4817776222a-d933-4b64-9921-fc6ed192589f12022-10-06
68001-481-48GM - Gram68001-4819fa4ec38-492c-43b4-8766-50e1808e083812022-10-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68001-48168001-481-45, 68001-481-47, 68001-481-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact identifier
ndc (package): 68001-481-47
ndc (package): 68001-481-45
ndc (package): 68001-481-48
ndc (product): 68001-481
ndc11 (package): 68001048147
ndc11 (package): 68001048145
ndc11 (package): 68001048148
spl id: 097d4e93-7f8b-53f8-e063-6294a90a4e40
spl set id: b564f971-2a9b-a605-e053-2995a90aee69

Reported adverse events (FAERS/openFDA)#

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