FDA.reportPublic FDA data

Budpak Antifungal Miconazole Nitrate Cream

Manufacturer
Budpak Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date
2013-11-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:38

Label at a glance#

ProductBudpak Antifungal Miconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Miconazole Nitrate 2.0%

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

  • cures most athlete's foot, jock itch, and ringworm.
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

WARNINGS SECTION

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop using this product and ask a doctor

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
  • do not use for diaper rash

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • wash affected area and dry thoroughly

  • Apply a thin layer 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 a day

  • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks

  • if conditions persist longer, ask a doctor

  • this product is not effective on the scalp or nails.

SPL UNCLASSIFIED SECTION

Other information

  • Store between 15ºC to 30º C (59ºF to 86º F)
  • Lot No. & Exp. Date: see crimp of tube.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Benzoic Acid, Butylated Hydroxy Anisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Antifungal Cream

Miconazole Nitrate 2%

Antifungal for Athlete’s Foot and Jock Itch

NET WT 0.5 OZ (14 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of package labelimage of package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
998483miconazole nitrate 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27293-023-012020-01-31C16284748780-19d75b9d0-2b78-f424-e053-dadaa90a57ceBudpak Antifungal Miconazole Nitrate Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27293-023-01Budpak Antifungal Miconazole Nitrate1 in 1 BOXCREAM11
27293-023-14Budpak Antifungal Miconazole Nitrate14 g in 1 TUBECREAM141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27293-023BUDPAK ANTIFUNGAL MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [BUDPAK INC. ]1Legacy NDC, 2 package rows20131203_1a156ca6-b290-4ab8-9efa-1ceebeabf7c2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K1
MICONAZOLEACTIVE MOIETY7NNO0D7S5M1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G501
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X51
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
27293-02327293-023-14, 27293-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
MINERAL OILT5L8T28FGPIACT
PEG-5 OLEATE0240V77G50IACT
PEGOXOL 7 STEARATE3EW5AXE5X5IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / RECTAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSUSPENSION / ORAL15 mgExact identifier — unii candidate
23 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / VAGINAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UGRANULE, FOR SUSPENSION / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / IRRIGATION0.02 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UFILM / SUBLINGUAL0.08 mgExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii candidate
23 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCAPSULE / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii candidate
4 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / VAGINAL10 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USOLUTION / ORAL5 mgExact identifier — unii candidate
24 equally ranked IID candidates
PEG-5 OLEATEPEG-5 OLEATE0240V77G50SUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
5 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCONCENTRATE / ORAL12.5 mg/5mlExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMMOUTHWASH / BUCCALNAExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMINJECTION, SOLUTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
23 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCAPSULE, LIQUID FILLED / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCONCENTRATE / ORAL0.08 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
PEG-5 OLEATEPEG-5 OLEATE0240V77G50CREAM / TOPICAL98 mgExact identifier — unii candidate
5 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UGEL / TOPICAL7 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / RECTAL11 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii candidate
23 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5LOTION / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
PEG-5 OLEATEPEG-5 OLEATE0240V77G50LOTION / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2ULOTION / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / TOPICAL0.01 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UOINTMENT / VAGINAL0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCREAM / TOPICAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USYRUP / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates

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
37440f2f-0bc8-4799-8a1e-514b8d86a3881a156ca6-b290-4ab8-9efa-1ceebeabf7c22013-11-29WarningsExact identifier
spl id: 37440f2f-0bc8-4799-8a1e-514b8d86a388
spl set id: 1a156ca6-b290-4ab8-9efa-1ceebeabf7c2

Reported adverse events (FAERS/openFDA)#

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