ELIXIRTRIPLEGUARD TRIPLE ANTIBIOTIC- miconazole nitrate cream cream

ElixirTripleGuard by

Drug Labeling and Warnings

ElixirTripleGuard by is a Otc medication manufactured, distributed, or labeled by ELIXIR HEALTHCARE USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each gram)

Miconazole Nitrate 2%w/w

Purpose

Antifungal

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

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

Avoid contact with eyes

Stop use and ask a doctor if

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

Keep out of reach of children

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

Directions

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

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

Store between 15-30°C (59-86°F)

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

INGREDIENTS AND APPEARANCE

ELIXIRTRIPLEGUARD   TRIPLE ANTIBIOTIC
miconazole nitrate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84546-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETEARETH-20 (UNII: YRC528SWUY)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
IMIDAZOLIDINYL UREA (UNII: M629807ATL)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CETEARYL SULFATE (UNII: 7ZBS06BH4B)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84546-0007-1	113 g in 1 TUBE; Type 0: Not a Combination Product	12/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	12/31/2025

Labeler - ELIXIR HEALTHCARE USA, LLC. (084920892)