HYDROCORTISONE- hydrocortisone cream 
J&A Digital Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only.

Do not use

for the treatment of diaper rash. Consult a doctor.

Stop use and ask a doctor if

  • condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
  • you begin use of any other hydrocortisone product
  • bleeding occurs

Keep out of reach of children.

If swallowed contact a Poison Control Center right away.

Directions

Inactive ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Package Labeling:

Label

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82942-1003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82942-1003-10.9 g in 1 PACKET; Type 0: Not a Combination Product05/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/08/2023
Labeler - J&A Digital Inc. (040268672)

Revised: 5/2023
Document Id: fb407714-dde8-d3d2-e053-6294a90a6197
Set id: ff95a536-35b3-4006-b43c-cce359e86aa9
Version: 2
Effective Time: 20230509
 
J&A Digital Inc.