New World Imports, 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.


Drug Facts

Active Ingredient

Hydrocortisone 1%



Keep out of reach of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.


Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor


For external use only

Do not use:

For the treatment of diaper rash.  Ask a doctor

In the genital if you have a vaginal discharge.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not use more than directed unless told to do so by a doctor.

Do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if:

Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have asked a doctor.

Rectal bleeding occurs


for itching of skin irritation, inflammation and rashes:

For external anal and genital itching, adults:

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin


hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone Acetate1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Propylene Glycol (UNII: 6DC9Q167V3)  
Petrolatum (UNII: 4T6H12BN9U)  
Mineral Oil (UNII: T5L8T28FGP)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Chlorocresol (UNII: 36W53O7109)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (White Cream) Score    
FlavorImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-050-0128 g in 1 TUBE; Type 0: Not a Combination Product04/27/2016
2NDC:51824-050-14144 in 1 CONTAINER05/01/2022
2NDC:51824-050-09.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/11/2016
Labeler - New World Imports, Inc (075372276)

Revised: 1/2022
Document Id: 2d455e59-2b78-4945-9fbd-b5c64e265c66
Set id: ea656cf8-cad5-4fa5-82e7-daec77a0bb04
Version: 5
Effective Time: 20220105
New World Imports, Inc