PRO-EX

Manufacturer
Natureplex, LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:50:07

Label at a glance#

ProductPRO-EX Anti Fungal
Active ingredientClotrimazole
Label structure10 sections

Indications and uses

cures most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling and discomfort

Dosage and administration

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in 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...

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in 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

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

PRINCIPAL DISPLAY PANEL - 42 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natureplex™

NATUREPLEX
QUALITY
GUARANTEED

Pro-Ex
clotrimazole cream

NET WT. 1.5 Oz.
(42g)

Principal Display Panel - 42 g Tube Carton
Principal Display Panel - 42 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN13
309367clotrimazole 10 MG/ML Topical CreamSCD13
309367clotrimazole 1 % Topical CreamSY13

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
67234-014-01PRO-EXAnti Fungal42 g in 1 TUBECREAM4213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-014PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]13Legacy NDC, 1 package rows20250101_be06dd85-e342-4f07-b0e4-c49b3f6b3b4b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H6511
ClotrimazoleACTIVE MOIETYG07GZ97H6511
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X11
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E11
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN11
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW11
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB11
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE411
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T11
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP11
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP11
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK11
WATERINACTIVE INGREDIENT059QF0KO0R11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-01467234-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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 6 · 305 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / ORAL33.34 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / INTRAVENOUS30 mgExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
9 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE TRISODIUMEDETATE TRISODIUM420IP921MBCREAM / TOPICALNAExact identifier — unii candidate
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii candidate
22 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
c4a82ce8-4b6f-41f0-9575-8bca9340f0b8be06dd85-e342-4f07-b0e4-c49b3f6b3b4b2024-12-31WarningsExact identifier
spl id: c4a82ce8-4b6f-41f0-9575-8bca9340f0b8
spl set id: be06dd85-e342-4f07-b0e4-c49b3f6b3b4b

Reported adverse events (FAERS/openFDA)#

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