MedPath
FDA Product

hydrocortisone

Product approved by U.S. Food and Drug Administration (US)

Basic Information

hydrocortisone

63629-8668

Regulatory Information

63629-8668

ANDA089074

C73584

July 18, 2023

USA

Hydrocortisone Lotion USP, 2.5%

HUMAN PRESCRIPTION DRUG LABEL

103

Company Information

171714327

Active Ingredients

CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)

Code: 4Q93RCW27E

Class Code: IACT

POLYOXYL 20 CETOSTEARYL ETHER

Code: YRC528SWUY

Class Code: IACT

ISOPROPYL PALMITATE

Code: 8CRQ2TH63M

Class Code: IACT

DEHYDROACETIC ACID

Code: 2KAG279R6R

Class Code: IACT

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

DMDM HYDANTOIN

Code: BYR0546TOW

Class Code: IACT

LACTIC ACID, UNSPECIFIED FORM

Code: 33X04XA5AT

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

LIGHT MINERAL OIL

Code: N6K5787QVP

Class Code: IACT

MYRISTYL ALCOHOL

Code: V42034O9PU

Class Code: IACT

PEG-100 STEARATE

Code: YD01N1999R

Class Code: IACT

MYRISTYL LACTATE

Code: 1D822OC34X

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM PYRROLIDONE CARBOXYLATE

Code: 469OTG57A2

Class Code: IACT

HYDROCORTISONE

Quantity: 25 mg in 1 mL

Code: WI4X0X7BPJ

Class Code: ACTIB

STEARYL ALCOHOL

Code: 2KR89I4H1Y

Class Code: IACT

Active Moieties

HYDROCORTISONE

Code: WI4X0X7BPJ

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