HYDROCORTISONE - hydrocortisone cream 
NeoPharm Co., Ltd.

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.

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Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:

Other uses of this product:  ask a doctor

Warnings

For external use only

Do not use

  • in or near the eyes
  • by putting directly into the rectum by using fingers or any mechanical device or applicator
  • for external feminine itching if you have a vaginal discharge
  • for diaper rash; ask a doctor

Ask a doctor or pharmacist before use if you are

using any other hydrocortisone product

When using this product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • rectal bleeding occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control

Directions

Other information

Cetyl alcohol, Butylated hydroxytoluene, Glycerin, Glyceryl monostearate, Isopropyl myristate, Myristoyl/palmitoyl/oxostearamide/arachamide MEA, Methylparaben, PEG-15 glyceryl stearate, Squalane, Stearic acid, Propylparaben, Purified water

Hydrocortisoneimage of carton label

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 h  in 100 g
Inactive Ingredients
Ingredient NameStrength
Cetyl alcohol (UNII: 936JST6JCN)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0065-11 in 1 BOX
128 g in 1 TUBE
2NDC:51141-0065-51 in 1 BOX
214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2010
Labeler - NeoPharm Co., Ltd. (631101883)
Registrant - NeoPharm Co., Ltd. (631101883)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture

Revised: 8/2010
Document Id: ff4b716a-95d0-4d1c-bea4-2fecd6bb5d3a
Set id: aaf91c65-8460-49a6-a331-582b3fb6cdce
Version: 2
Effective Time: 20100823
 
NeoPharm Co., Ltd.