FIFTHPULSE HYDROCORTISONE 1OZ- hydrocortisone ointment

FifthPulse Hydrocortisone 1oz by

Drug Labeling and Warnings

FifthPulse Hydrocortisone 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 HYDROCORTISONE 1OZ 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-014-01	28.4 g in 1 TUBE; Type 0: Not a Combination Product	07/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	07/16/2025

Labeler - Front Pharmaceutical PLC (530897792)

Registrant - Front Pharmaceutical PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
Front Pharmaceutical PLC		530897792	manufacture(69571-014)