FDA.reportPublic FDA data

ElixirTripleGuard

Manufacturer
ELIXIR HEALTHCARE USA, LLC.
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:32:57

Label at a glance#

ProductElixirTripleGuard Triple Antibiotic
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

Uses • For the treatment and prevention of most: • Athlete’s foot • Jock itch • Ringworm • Relieves itching, scaling, cracking, and discomfort associated with these conditions

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 healthcare professional • Supervise children in the use of this product. For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoe...

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Uses
• For the treatment and prevention of most:
• Athlete’s foot
• Jock itch
• Ringworm
• Relieves itching, scaling, cracking, and discomfort associated with these conditions

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 eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition persists or gets worse
• a rash or other allergic reaction develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

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 healthcare professional • Supervise children in the use of this product.

For athlete's foot:• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes •Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm:Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch:Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

Other information

SPL UNCLASSIFIED SECTION

• Store between 15-30°C (59-86°F)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Elixir

Elixir MycoTender

Miconazole Nitrate

Antifungal Cream

With 2% Micronazole

Nitrate

CURSE JOCK ITCH &

RING WORM SOOTHES

AND PROMOTES HEALING

4 Oz. (113) g

Tube Lable.jpgTube Lable.jpg

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84546-0007-1ElixirTripleGuardTriple Antibiotic113 g in 1 TUBECREAM1131

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84546-000784546-0007-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CETEARETH-20YRC528SWUYIACT
CETEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL STEARATE230OU9XXE4IACT
IMIDAZOLIDINYL UREAM629807ATLIACT
PEG-100 STEARATEYD01N1999RIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CETEARYL SULFATE7ZBS06BH4BIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
ndc (package): 84546-0007-1
ndc (product): 84546-0007
ndc11 (package): 84546000701
spl id: 48749d03-2194-b2d4-e063-6394a90a731f
spl set id: 0482ce9f-c98a-4f37-8b37-6df1738b6da3

Reported adverse events (FAERS/openFDA)#

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