FDA.reportPublic FDA data

Fungoid Tincture Treatment Kit

Manufacturer
Pedinol Pharmacal, Inc. | EMS Contract Packaging
Effective date
2018-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:44:48

Label at a glance#

ProductFungoid Tincture Treatment Kit
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

• cures most athlete's foot (tinea pedis) and ringworm (tinea corporis) • for effective relief of itchy, scaly skin between the toes

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 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 •...

Storage and handling

• store at controlled room temperature 15° - 30°C (59° - 86°F) • Protect from freezing. If freezing occurs, warm to room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Topical Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes

WARNINGS

WARNINGS SECTION

  • for external use only.

OTC - DO NOT USE SECTION

  • do not use on children under 2 yrs unless directed by a doctor.

OTC - WHEN USING SECTION

  • avoid contact with eyes.
  • if irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

If swallowed, seek medical attention immediately.

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 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
  • this product is not effective on scalp or nails

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water

SPL UNCLASSIFIED SECTION

Retain product insert for full directions and warnings

Questions or comments?

OTC - QUESTIONS SECTION

1-800-PEDiNOL (733-4665) or visit www.pedinol.com

Principal Display Panel – Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0884-5493-01

PEDiNOL™

fungoid® tincture

treatment kit

miconazole nitrate 2%

topical antifungal

net contents:

fungoid® tincture 1 fl. oz.

nail scrub™ 2 oz.

pedi-nail brush

Fungoid Tincture Treatment Kit Carton
Fungoid Tincture Treatment Kit Carton

Principal Display Panel – Nail Scrub Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0884-4891-02

PEDiNOL™

nail scrub™

nail rejuvenating,

cleansing & bleaching

agent

net wt. 2 oz. (56.7g)

Nail-Scrub-2oz-Label
Nail-Scrub-2oz-Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0884-5493-01EA - Each0884-5493fb09ae17-bf8c-470a-b19a-703b1eb2449012014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K1
MICONAZOLEACTIVE MOIETY7NNO0D7S5M1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063P1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
LAURETH-4INACTIVE INGREDIENT6HQ855798J1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0884-54930884-5493-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
ACETIC ACIDQ40Q9N063PIACT
BENZYL ALCOHOLLKG8494WBHIACT
ISOPROPYL ALCOHOLND2M416302IACT
LAURETH-46HQ855798JIACT
WATER059QF0KO0RIACT
WATER059QF0KO0RINGR
CALCIUM CARBONATEH0G9379FGKINGR
MINERAL OILT5L8T28FGPINGR
GLYCERYL MONOSTEARATE230OU9XXE4INGR
CETYL ALCOHOL936JST6JCNINGR
POLYSORBATE 60CAL22UVI4MINGR
SORBITAN MONOSTEARATENVZ4I0H58XINGR
PHENOXYETHANOLHIE492ZZ3TINGR
SODIUM HYPOCHLORITEDY38VHM5ODINGR
METHYLPARABENA2I8C7HI9TINGR
DIAZOLIDINYL UREAH5RIZ3MPW4INGR
PROPYLPARABENZ8IX2SC1OHINGR
EDETATE TRISODIUM420IP921MBINGR
SODIUM BENZOATEOJ245FE5EUINGR

Source Document#

Source XML · Source PDF

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 · 108 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION / PARENTERALADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / ORAL360 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY, METERED / NASAL5 mg/1mlExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRASYNOVIAL18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSUSPENSION / ORAL12 mgExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION / INTRAVENOUS827 mgExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PCREAM / TOPICALNAExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3 mgExact identifier — unii candidate
45 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
LAURETH-4LAURETH-46HQ855798JSOLUTION / TOPICAL5.22 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, SOLUTION / SUBCUTANEOUS4 mgExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PTABLET / ORALNAExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PCREAM / VAGINAL0.35 %w/wExact identifier — unii candidate
45 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PCAPSULE, COATED / ORAL1 mgExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION / INFILTRATIONNAExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS32 mgExact identifier — unii candidate
45 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
LAURETH-4LAURETH-46HQ855798JGEL / TOPICAL60 mgExact identifier — unii candidate
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSYRUP / ORAL10 mgExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
50 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / OPHTHALMIC3 mgExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / SOFT TISSUE40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSOLUTION / TOPICALADJ PHExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRACAVITARY0.01 mlExact identifier — unii candidate
50 equally ranked IID candidates
ACETIC ACIDACETIC ACIDQ40Q9N063PSUSPENSION/ DROPS / AURICULAR (OTIC)0.04 %w/vExact identifier — unii candidate
45 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 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
93d240cc-c8e2-40ad-89e4-860b337b6fd7b250f4a4-6fdf-4a91-b214-4447aec3bb332018-12-03WarningsExact identifier
spl set id: b250f4a4-6fdf-4a91-b214-4447aec3bb33

Reported adverse events (FAERS/openFDA)#

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