FDA.reportPublic FDA data

Triple Paste Antifungal Ointment

Manufacturer
Advantice Health, LLC
Effective date
2026-03-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:50:50

Label at a glance#

ProductTriple Antifungal
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

For the treatment of superficial skin infections caused by yeast (Candida albicans) Relieves discomfort, irrit.ation, redness and chafing associated with jock itch Cures most jock itch (tinea cruris)

Dosage and administration

Clean affected area and dry thoroughly Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product Use daily for 2 weeks; If condition persists longer, consult a doctor This product is not effective on the scalp or nails

Storage and handling

Store at room temperature 15°– 30°C (59°– 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of superficial skin infections caused by yeast (Candida albicans)
  • Relieves discomfort, irrit.ation, redness and chafing associated with jock itch
  • Cures most jock itch (tinea cruris)

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 2 weeks

OTC - DO NOT USE SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean affected area and dry thoroughly
  • Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • 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

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

Questions?

OTC - QUESTIONS SECTION

1-800-345-0032

SPL UNCLASSIFIED SECTION

Distributed by Advantice Health, LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Paste AF ®

2% MICONAZOLE NITRATE ANTIFUNGAL OINTMENT

  • Relieves burning, redness,
    irritation and discomfort
  • Unique, soothing,
    water-resistant formula
  • Lubricates skin to heal
    and prevent chafing

Help is on the way...

Net Wt. 2 oz (56.7 g)

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998442miconazole nitrate 2 % Topical OintmentPSN4
998460Triple Paste AF 2 % Topical OintmentPSN4
998460miconazole nitrate 0.02 MG/MG Topical Ointment [Triple Paste AF]SBD4
998442miconazole nitrate 0.02 MG/MG Topical OintmentSCD4
998442miconazole nitrate 2 % Topical OintmentSY4
998460Triple Paste AF 0.02 MG/MG Topical OintmentSY4
998460Triple Paste AF 2 % Topical OintmentSY4

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130316864040022GTIN-13: 0316864040022
EAN-13: 0316864040022
GTIN-12: 316864040022
UPC-A: 316864040022
GTIN storage (14 digits): 00316864040022		TPUS006102_Triple Paste AF 2oz Carton_live.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-040-02Triple Antifungal1 in 1 CARTONOINTMENT14
16864-040-02Triple Antifungal56.7 g in 1 TUBEOINTMENT56.74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-040-02GM - Gram16864-040ceb2217b-cc17-49f3-94c1-b56c905b23e612023-01-09

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16864-04016864-040-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
STARCH, CORNO8232NY3SJIACT
LANOLIN7EV65EAW6HIACT
STEARYL ALCOHOL2KR89I4H1YIACT
YELLOW WAX2ZA36H0S2VIACT
LEVOMENOL24WE03BX2TIACT
CHOLESTEROL97C5T2UQ7JIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATZ6J799EAJKIACT

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
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsExact identifier
ndc (package): 16864-040-02
ndc (product): 16864-040
ndc11 (package): 16864004002
spl id: 4d63f2a2-f113-d739-e063-6394a90a2d27
spl set id: 9a47fb1b-a41f-4c8a-8e43-7332853c308e

Reported adverse events (FAERS/openFDA)#

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