FIFTHPULSE MICONAZOLE NITRATE CREAM 1OZ- miconazole nitrate cream

FifthPulse Miconazole Nitrate Cream 1oz by

Drug Labeling and Warnings

FifthPulse Miconazole Nitrate Cream 1oz by is a Otc medication manufactured, distributed, or labeled by Front Pharmaceutical PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIFTHPULSE MICONAZOLE NITRATE CREAM 1OZ 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
STEARIC ACID (UNII: 4ELV7Z65AP)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color		Score
Shape		Size	105mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-016-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	07/19/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	07/19/2025

Labeler - Front Pharmaceutical PLC (530897792)

Registrant - Front Pharmaceutical PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
Front Pharmaceutical PLC		530897792	manufacture(69571-016)